医疗器械监督管理条例 Regulations for the Supervision and Administration of Medical Devices

医疗器械监督管理条例第一章总则第一条为加强对医疗器械的监督管理，保障人民群众的生命安全和身体健康，根据《中华人民共和国药品管理法》等法律法规，制定本条例。

第二条本条例适用于在中华人民共和国境内生产、销售、使用和进口医疗器械的行为。

第三条医疗器械的监督管理应该科学、公正、严格、高效的原则，根据医疗器械的不同特点和风险程度，进行分类管理。

第四条国家药品监督管理局负责全国医疗器械的监督管理工作，地方人民政府卫生行政部门负责本行政区域内医疗器械的监督管理工作。

第五条医疗器械的生产、销售、使用和进口应当符合国家法律法规以及相关标准的规定，不得损害人民群众的生命安全和身体健康。

第六条国家鼓励和支持医疗器械技术的研发和创新，提升医疗器械的质量和安全水平。

第二章医疗器械的生产和销售第七条医疗器械的生产企业应当依法小额贷款手续，注册登记，取得《医疗器械生产许可证》，并按照该许可证的规定进行生产。

第八条医疗器械的销售企业应当依法成立，具备一定的资金、场所、设备和人员，取得《医疗器械销售许可证》，并按照该许可证的规定进行销售。

第九条医疗器械生产企业应当建立和实施医疗器械质量管理体系，确保产品质量符合国家标准和技术要求。

第十条医疗器械销售企业应当在销售点明显位置设置医疗器械销售许可证的标识，严禁销售未取得许可证的医疗器械。

第十一条医疗器械广告应当真实、准确、合法，不得含有虚假、夸大和误导性的宣传内容。

第十二条医疗器械销售企业应当建立和健全售后服务体系，及时处理用户的投诉和意见，并向监督部门报告医疗器械发生的不良事件和质量问题。

第三章医疗器械的使用和管理第十三条医疗机构应当配备专业的医疗器械管理人员，负责医疗器械的购买、验收、存储和使用。

第十四条医疗机构应当对医疗器械进行全面的质量检测，确保符合要求后方可投入使用。

第十五条医疗机构应当建立和实施医疗器械的定期检验和维修计划，及时检验和维修医疗器械，确保其正常工作。

第十六条医疗机构对医疗器械发生的不良事件和质量问题应当及时报告监督部门，并按照相关规定采取相应的处置措施。

医疗器械监督管理条例（2000年1月4日中华人民共和国国务院令第276号公布 2014年2月12日国务院第39次常务会议修订通过根据2017年5月4日《国务院关于修改〈医疗器械监督管理条例〉的决定》修订）第一章总则第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。

第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。

第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。

国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。

县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。

第四条国家对医疗器械按照风险程度实行分类管理。

第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。

国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。

制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。

医疗器械分类目录应当向社会公布。

第五条医疗器械的研制应当遵循安全、有效和节约的原则。

国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。

第六条医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。

Measures for the Supervision and Administration of Medical Device ProductionOrder of the State Food and Drug Administration [2004] No.12July 20, 2004The present Measures for the Supervision and Administration of Medical Device Production were deliberated upon and adopted at the executive meeting of the State Food and Drug Administration on June 25, 2004 and are hereby promulgated. They shall be implemented as of the promulgation date.Director General: Zheng XiaoyuMeasures for the Supervision and Administration of Medical Device ProductionChapter I General ProvisionsArticle 1 These Measures have been formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices so as to strengthen the supervision and administration of medical device production, regulate the order of production, and guarantee that the medical devices will be safe and effective.Article 2 The term supervision and administration of medical device production shall refer to those administrative activities carried out by the (food) drug administration departments in accordance with the law such as examining the conditions and processes of medical device production, granting permits, conducting supervision and inspections, and etc.Article 3 The State Food and Drug Administration shall be in charge of the supervision and administration of medical device production throughout China. Each local department of (food) drug administration at the county level or above shall take charge of supervising and administering medical device production within its own jurisdiction.Chapter II Applications for the Establishment of Medical Device Production Enterprises and the Examination and Approval ThereofArticle 4 The establishment of a medical device production enterprise must conform to the development planning of the State and the industrialpolicies for the medical device industry.Article 5 The State Food and Drug Administration shall, in accordance with the Regulations on the Supervision and Administration of Medical Devices, make specific provisions regarding the conditions for the establishment of medical device production enterprises and formulate corresponding quality management rules for medical device production regarding different classes of medical devices as well as organize the implementation thereof.Article 6 In order to establish a Class 1medical device production enterprise, the applicant must meet those conditions for production which are suitable for the products, and must, within 30 days of obtaining the business license, complete the Form on the Registration of a Class 1 Medical Device Production Enterprise (see Appendix 1 of these Measures) and inform the local department of (food) drug administration in the province, autonomous region, or municipality directly under the administration of the Central Government in writing.Article 7 In order to establish a Class 2 or 3 medical device production enterprise, the following conditions must be met:1. The persons in charge of production, quality and technology for the enterprise must have the professional capacities suitable for the produced medical devices and grasp the relevant laws, regulations, and rules of the State regarding medical device supervision and administration as well as all other relevant provisions regarding product quality and technology. The person in charge of quality may not concurrently hold the position of the person in charge of production.2. The proportion of the enterprise's technicians with junior titles or above or with diplomas from technical secondary schools or above among the total number of employees must comply with the product requirements.3. The enterprise must have the production equipment, production and warehousing locations, and an overall environment which are suitable for the products and the production scale. If the enterprise produces medical devices with particular requirements in respect to the environment, equipment, or etc., it must conform to the national standards, industry standards, and relevant provisions of the State.4. The enterprise must establish a quality inspection institution and have the quality inspection capacity suitable for the produced variety and the production scale.5. The enterprise must preserve the laws, regulations, and rules related to medical device production and management as well as the relevant technical standards.Article 8 In order to establish a Class 3 medical device production enterprise, the applicant must, in addition to meeting the requirements in Article 7 of these Measures also meet the following conditions: 1. There must be no less than two internal examiners who meet the quality management system requirements.2. There must be no less than two full-time technicians with medium titles or above or diplomas of junior college or above in the relevant major.Article 9 In order to establish a Class 2 or 3 medical device production enterprise, the applicant must file an application with the department of (food) drug administration in the province, autonomous region, or municipality directly under the administration of the Central Government where the enterprise will be located, complete the Application Form for the Permit for the Medical Device Production Enterprise (Establishment) (see Appendix 2 of these Measures), and submit the following materials: 1. The basic information regarding the legal representative and the person in charge of the enterprise and their eligibility testimonials.2. The notice issued by the administration for industry and commerce on the pre-ratification of the name of the enterprise to be established.3. The testimonial on the production site.4. The curriculum vitae, diploma, or title certificate of each person in charge of the enterprise's production, quality, and technology as well as registration forms of relevant professional technicians and technical workers which must indicate their departments and positions. The form on the proportions of the senior, medium, and junior technicians must also be included.5. The scope and varieties of the products to be produced and a brief introduction about the relevant products.6. A catalogue of the main production equipment and inspection equipment.7. A catalogue of the production quality management documents.8. The process flow diagram regarding the products to be produced which must indicate the main control items and control points.9. A production environment test report must be provided if sterile medical devices are to be produced.The applicant shall be responsible for the authenticity of all contents in the application materials.Article 10 The department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government shall, after receipt of the application, process the application separately in light of the following circumstances: 1. If the applied-for matter is does not legally fall within the scope of power of the department of (food) drug administration, the department of (food) drug administration shall immediately make a decision ofnon-acceptance regarding the application and advise the applicant to apply to the relevant administrative department.2. If there exists in the application materials any error that is correctable on site, the department of (food) drug administration shall permit the applicant to make an on site correction.3. In the event that the application materials are not complete or do not meet the formal examination requirements, the department of (food) drug administration shall, either on site or within 5 working days, issue a Notice on Supplemental Materials to the applicant informing the applicant at once of all the contents that need to be supplemented. If it fails to inform the applicant within the specified time limit, it shall be deemed to have accepted the application as of the receipt of the application materials.4. In the event that the application materials are complete and meet the formal examination requirements or the applicant has submitted all of the application materials required to be supplemented, the department of (food) drug administration shall accept the application.In the event that the department of (food) drug administration of a province, autonomous region, or municipality directly under the administration of the Central Government accepts or refuses to accept an application for the establishment of a medical device production enterprise, it shall issue a Notice on Acceptance of the Application or a Notice on the Refusal of the Application which shall be dated and affixed with its special acceptance stamp.Article 11 In regard to an application for the establishment of a Class 2 or 3 medical device production enterprise, the department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government shall, within 30 working days as of acceptance, examine the application in accordance with Articles 7 through 9 of these Measures and the medical device production quality management rules as promulgated by the State Food and Drug Administration. If the classified implementation requirements of the medical device production quality management rules have not been promulgated for implementation, the application shall be examined in accordance with Articles 7 through 9 of these Measures.If the application is determined to be qualified, the department of (food) drug administration shall make a written decision on the approval of the issuance of the permit and shall issue the Permit for the Medical Device Production Enterprise (see Appendix 7 of these Measures) within 10 working days. If, however, the application is determined to be unqualified, the said department of (food) drug administration shall make a written decision on the refusal of the issuance of the permit, state the reasons thereof, and also inform the applicant of its right to apply for anadministrative reconsideration or to file an administrative lawsuit.Article 12 The department of (food) drug administration of a province, autonomous region, or municipality directly under the administration of the Central Government shall announce the conditions, procedures, and time limit for applying for the Permit for the Medical Device Production Enterprise as well as a catalogue of all the materials to be submitted, a demonstration text of the application letter, and etc. on its website and in the workplace of the administrative department.The department of (food) drug administration of a province, autonomous region, or municipality directly under the administration of the Central Government shall publicize the relevant information regarding the issuing of the Permit for Medical Device Production Enterprises and the public shall have the right to consult the information.Article 13 The department of (food) drug administration of a province, autonomous region, or municipality directly under the administration of the Central Government shall, upon examining an application for the establishment of a medical device production enterprise, announce the process and result of the examination. The applicant and the interested party may present a statement or defense by submitting its written opinions on the matter as directly related to its major interests.Article 14 In the event that an application for the establishment of a medical device production enterprise directly involves a major interest relationship between the applicant and others, the department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government shall inform the applicant and the interested party so that they may, in accordance with the laws, regulations, and other provisions of the State Food and Drug Administration, enjoy the right to apply for a hearing. Upon examining an application for the establishment of a medical device production enterprise, the department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government shall announce to the public the major permitted matter if it considers that the matter involves public interests and shall hold a hearing in this regard.Chapter III The Administration of Permits for Medical Device Production EnterprisesArticle 15 A Permit for the Medical Device Production Enterprise shall include the original copy and the counterpart and both shall have equal legal binding force with a 5 year term of validity.The Permits for Medical Device Production Enterprises shall be uniformly printed by the State Food and Drug Administration.Article 16 A Permit for the Medical Device Production Enterprise shall state the permit number, the enterprise name, the legal representative, the person in charge of the enterprise, the registered address, the production address, the production scope, the permit issuing department, the date of issuance, the term of validity, and etc.The production scope must include the product management category, the medical device classification catalogue code, and the product name.Article 17 The term modification of a Permit for the Medical Device Production Enterprise shall include the modification of permitted matters and the modification of registered matters.The term modification of a permitted matter shall include the modification of the legal representative, the person in charge of the enterprise, the registered address, the production address, or the production scope. The term modification of a registered mattershall include the modification of any matter other than the abovementioned matters.Article 18 In the event that a medical device production enterprise modifies a permitted matter, it must, 30 days prior to the modification of the original permitted matter, complete the Application Form for the Permit for the Medical Device Production Enterprise (Modification) (see Appendix 3 of these Measures), submit the relevant materials involving the modified content with reference to Article 9 of these Measures, and apply to the original permit issuing department for the modification registration of the Permit for the Medical Device Production Enterprise. The original permit issuing department shall, within 15 working days as of the receipt of the application for modification and the application materials for modification from the enterprise, make a decision on whether or not to approve the modification. If the modification is approved, it shall recover the old permit and issue a new one. The expiry date of the valid term of the modified Permit for the Medical Device Production Enterprise shall remain unchanged. If, however, the modification is not approved, it shall state the reason for the refusal in writing and inform the applicant of the right to apply for an administrative reconsideration or to file an administrative lawsuit.The medical device production enterprise must, after completing the formalities for the modification of a permitted matter in the Permit for the Medical Device Production Enterprise in accordance with the law, go to the administration for industry and commerce to complete the formalities for the modification of its registration in a timely manner.Article 19 In the event that a medical device production enterprise modifies a registered matter in the Permit for the Medical Device Production Enterprise, it must, within 30 days after the administration for industry and commerce ratifies the modification, complete the Application Form for the Permit for the Medical Device Production Enterprise (Modification) (see Appendix 3 of these Measures), and apply to the original permit issuing department for the modification registration of the Permit for the Medical Device Production Enterprise. The original permit issuing department shall, within 15 working days of receiving the application for modification and the application materials for modification from the enterprise, handle the modification for the said enterprise. If the application is qualified, the original permit issuing department shall recover the old permit and issue a new one. The expiry date of the valid term of the modified Permit for the Medical Device Production Enterprise shall remain unchanged.Article 20 In the event that a Class 2 or 3 medical device production enterprise of is merged, divided, or moved out of its original jurisdictional location, it must re-apply for the Permit for the Medical Device Production Enterprise in accordance with Articles 7 through 9 of these Measures.In the event that a Class 1 medical device production enterprise of is merged, divided, moved out of the original jurisdictional location, or requests the modification of a registered matter, it must, within 30 days after obtaining the new business license or after requesting the modification of the registered matter, inform the local department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government in writing in accordance with Article 6 of these Measures.Article 21 In the event that a Class 2 or 3 medical device production enterprise of intends to establish its production site in another province, but has not formed an independent production enterprise, it must file an application with the original examination and approval department, complete the Form on the Registration of the Trans-provincial Production Site Established by the Class 2 or 3 Medical Device Production Enterprise (see Appendix 4 of these Measures), and submit the relevant materials to apply for the modification registration of the Permit for the Medical Device Production Enterprise. The original examination and approval department shall handle the matter with reference to Paragraph 1 of Article 18 of these Measures. If the modification is approved, the original examination and approval department shall forward the modification to the department of (food) drug administration of the province, autonomous region, or municipality directly under theadministration of the Central Government where the production site is located.In the event that a Class 1 medical device production enterprise intends to establish its production site in another province, but has not formed an independent production enterprise, it must inform the original registration informing department in writing in accordance with Paragraph 2 of Article 20 of these Measures. The original registration informing department shall, after receiving the written information, forward the facts to the department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government where the production site is located.In the event that a medical device production enterprise intends to establish its production site in another province and has formed an independent production enterprise, it must apply for the Permit for the Medical Device Production Enterprise in accordance with Articles 7 through 9 of these Measures, or must, in accordance with Article 6 of these Measures, make informing registration of the Class 1 medical device production enterprise. The department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government where the newly established production site is located shall, after the issuance of the Permit for the Medical Device Production Enterprise or receipt of the written information regarding the Class 1 medical device production enterprise, forward the facts to the original examination and approval department or the original registration informing department.(Relevant articles: Legislation 1)Article 22 In the event that a medical device production enterprise needs to continue its production after expiry of the valid term of its Permit for the Medical Device Production Enterprise, it must, 6 months prior to the expiry of the valid term, file an application with the original permit issuing department for the issuance of a new Permit for the Medical Device Production Enterprise to replace the old one, complete the Application Form for the Permit for the Medical Device Production Enterprise (Replacement) (see Appendix 5 of these Measures), and submit those materials as prescribed in Article 9 of these Measures that have been changed since the original issuance of the Permit for the Medical Device Production Enterprise or since the replacement of the Permit for the Medical Device Production Enterprise.The original permit issuing department shall, in light of the implementation of the laws and regulations by the enterprise and the information on the product supervision sampling and quality system operation, examine the application in contrast to Article 11 of these Measures and make a decision on whether or not to issue a new Permit forthe Medical Device Production Enterprise to replace the old one. If the application is determined to be qualified, the original permit issuing department shall recover the old permit and issue a new one. If, however, the application is determined to be unqualified, the original permit issuing department shall make a written decision regarding their refusal to replace the permit, state the reasons therefore, and also inform the applicant of its right to apply for an administrative reconsideration or to file an administrative lawsuit.The department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government shall, according to the application of the medical device production enterprise and prior to the expiry of the valid term of the Permit for the Medical Device Production Enterprise, make a decision on whether or not to approve the issuance of a new permit to replace the old one. If it fails to make the decision within the specified time limit, it shall be deemed to have consented to the replacement and shall complete the corresponding formalities.Article 23 In the event that a Permit for the Medical Device Production Enterprise is lost, the medical device production enterprise must immediately apply to the original permit issuing department for the issue of a replacement and publish a statement regarding the loss via a medium as designated by the original permit issuing department. The original permit issuing department shall, within 10 working days after the 1 month expiration date from of the day upon which the enterprise published the statement regarding the loss, issue a new Permit for the Medical Device Production Enterprise in light of the originally ratified matter.Article 24 The department of (food) drug administration of a province, autonomous region, or municipality directly under the administration of the Central Government shall establish working archives on ratification, issuance, replacement, and modification, re-issuance, revocation and nullification of the Permits for Medical Device Production Enterprises and shall, at the end of each quarter, submit the ratification, issuance, replacement, modification, re-issuance, revocation, nullification, or etc. of the Permits for Medical Device Production Enterprises to the State Food and Drug Administration. A Permit for the Medical Device Production Enterprise which is recovered or invalidated due to modification, replacement, revocation, cancellation, nullification, or etc. shall be kept in archives for 5 years.Article 25 No entity or individual shall alter, buy and sell at a profit, lease, lend, or illegally assign by any other means the Permit for the Medical Device Production Enterprise.Chapter IV Administration of Production of Medical Devices upon EntrustmentArticle 26 The entrusting party for the production of medical devices must be a production enterprise which has obtained the Permit for the Medical Device Production Enterprise or has completed the informing registration for a Class 1 medical device production enterprise Measures and has obtained the medical device registration certificate.Article 27 The entrusted party for the production of medical devices must be a production enterprise which has obtained the Permit for the Medical Device Production Enterprise or has completed the informing registration for a Class 1 medical device production enterprise Measures and must meet the following conditions:1. Its production scope must cover the medical devices to be produced upon entrustment.2. Its conditions for production, testing capacities, and quality management system must be suitable for the medical devices to be produced upon entrustment.3. In regard to sterile medical devices for one time use only and medical devices otherwise prescribed by the State Food and Drug Administration, the entrusted party must, in addition to conforming to the abovementioned provisions, have the medical device registration certificate for the products to be produced upon entrustment.Article 28 The entrusting party must take charge of the quality and sale of the medical devices to be produced upon entrustment. The entrusting party must make a detailed inspection of the production conditions of the entrusted party, production technology level and quality management situation, provide the entrusted party with the technical and quality documents on the medical devices to be produced upon entrustment, and guide and supervise the whole process of production.The entrusted party must carry out the production according to the product standards and production process prescribed in the medical device registration certificate for the product to be produced upon entrustment and preserve all the documents and records on the production upon entrustment in accordance with the provisions.Article 29 The entrusting party and the entrusted party to the production of medical devices upon entrustment must conclude a written contract. The term of production upon entrustment as stipulated in the contract must not exceed the valid term of the medical device registration certificate for the product to be produced upon entrustment.Article 30 The entrusting party must, within 30 days as of concluding the contract, apply to the local department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government for registration and archival filing, complete the Form on the Registration of the Medical Devices to Be Produced upon Entrustment (see Appendix 6 of these Measures) and submit the following materials:1. Photocopies of the Permit for the Medical Device Production Enterprise or the Form on Registration of a Class 1Medical Device Production Enterprise and the business license of both the entrusting party and the entrusted party.2. Photocopies of the entrusting party's medical device registration certificate for the production of products upon entrustment and the entrusted party's medical device registration certificate for the relevant products.3. The product standards, production process, instructions, labels, and packing marks to be adopted for the production of the medical devices upon entrustment.4. A photocopy of the contract for production upon entrustment.5. The entrusting party's accreditation declaration regarding the entrusted party's quality management system.6. The entrusting party's self-guaranty declaration on the quality and sale of the medical devices and the after-sales service responsibilities. The department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government where the entrusting party is located shall, after the registration and archival filing, make a copy of the Form on Registration of the Medical Devices to Be Produced upon Entrustment to the department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government where the entrusted party is located.Article 31 In the event that a contract for production upon entrustment is terminated or any registered or archived content is changed, the entrusting party must report to the local department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government in a timely manner. The department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government where the entrusting party is located shall forward the fact to the department of (food) drug administration of the province, autonomous region, or municipality directly under the administration of the Central Government where the entrusted party is located in a timely。

Regulations for the Supervision and Administration of Medical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the People's Republic of China shall comply with the Regulation.Article 3 "Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Control of conception.Article 4 The drug regulatory authority under the State Council is responsible for supervision and administration of medical devices nationwide. The drug administration of the local government at county level and above is responsible for supervision and administration of medical devices in each administrative region. The drug regulatory authority under the State Council shall coordinate with other departments under the State Council, responsible for comprehensive economic administration, in the implementation of policies for the medical device industry.Article 5 The State shall classify medical devices and administer them based on this classificationClass I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;Class II Medical Devices are those for which further control is required to ensure their safety and effectivenessClass III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.The classification catalogue for medical devices shall be stipulated, adjusted and promulgated by the drug regulatory authority under the State Council, in accordance with classification principles after consulting with health authority under the State Council.Article 6 Medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metering law. The detailed product list shall be formulated and promulgated by the drug regulatory authority under the State Council, jointly with the metering authority.Chapter II The Administration of Medical DevicesArticle 7 The State encourages the research and development of new medical devices. "New medical devices" refer to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.The clinical trials of new medical devices of Class II and Class III can be conducted only after clinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council.New medical devices that have completed clinical trials and passed experts' evaluation and review organized by the drug regulatory authority under State Council, shall receive a new product certificate after being approved by the same organization.Article 8 The State shall implement a product registration system for the manufacturing of medical devices.Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Clinical evaluation must be conducted for Class II and Class III medical devices before they are put into production.Article 9 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial or verification of class II medical devices in their own administrative regions. The drug regulatory authority under the State Council is responsible for the inspection and approval of clinical trial or verification of class III medical devices.Clinical trial or verification shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The medical institutions shall conduct the clinical trial or verification, in accordance with the related provisions of the drug regulatory authority under the StateCouncil.The qualification of medical institutions engaged in the clinical trial or verification shall be certified by the drug regulatory authority, jointly with the health authority under the State Council.Article 10 Medical institutions may develop medical devices to serve their own clinical needs, and use them within their own institution under the guidance of licensed medical practitioners.Class II medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority of the government at provincial level and above. Class III medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority under the State Council.Article 11 When importing medical devices into China for the first time, the agent of the imported device, should submit the instruction for use, quality standards, testing methods, other relevant information, product samples, and marketing authorization certificates issued by the manufacturing countries (regions), for inspection and approval by the drug regulatory authority under the State Council, and receive an import product registration certificate before applying for customs formalities.Article 12 When applying for registration of medical devices, technical standards, testing report and other relevant information shall be submitted according to provisions of the drug regulatory authority under the State Council.The drug regulatory authority of the government of the municipality consisting of districts shall decide within 30 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 60 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority under the State Council shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.Article 13 In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change.Article 14 The term of validity for the registration certificate of medical devices is four years. The holder of the certificate shall apply for re-registration within six months before the certificate expires.When the manufacturing of a medical device is stopped continuously for more than 2 years, its registrationcertificate is automatically invalidated.Article 15 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.National standards of medical devices shall be formulated jointly by the standardization authority and the drug regulatory authority under the State Council. Professional standards of medical devices shall be formulated by the drug regulatory authority under the State Council.Article 16 The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.Article 17 The registration number of a medical device shall be marked on the product itself and the external package according to the provisions of the drug regulatory authority under the State Council.Article 18 The State implements a system of re-evaluation and obsolescence for medical devices, the details of which shall be formulated by drug regulatory authority under the State Council after consulting with other related authorities under the State Council.Chapter III Administration of Production, Distribution and Useof Medical DevicesArticle 19 Enterprises manufacturing medical devices shall meet the following conditions:1. Possess professional technical personnel required for the manufacture of its medical devices;2. Possess facility and environment required for the manufacture of its medical devices;3. Possess equipment required for the manufacture of its medical devices;4. Possess an establishment or personnel and equipment for quality testing required for the manufacture of its medical devices.Article 20 Establishment of manufacturing of class I medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing manufacturing of class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Manufacturing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Manufacturing Enterprise License.The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 21 Medical device manufacturing enterprises shall not start manufacturing products before obtainingthe manufacturing enterprise license.Article 22 The State implements a mandatory safety certification system for certain class III medical devices.A specific product list shall be established by the drug regulatory authority under the State Council, jointly with the quality and technology supervision authority.Article 23 Enterprises distributing medical devices shall meet the following conditions:1. Possess appropriate facility(s) and environment for the kind of medical devices to be distributed;2. Possess appropriate quality inspection personnel for the kind of medical devices to be distributed;3. Possess adequate ability for technical training, maintenance and after-sales services for the kinds of medical devices to be distributed;Article 24 Establishing of distribution of class II and/or class III medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing an enterprise distributing class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Distributing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Distributing Enterprise License.The term of validity of the Medical Device Distribution Enterprise License is 5 years. Upon expiration,re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 25 The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 30 working days whether the licenses for manufacturing or distributing enterprises of medical devices can be issued, counting from the date of acceptance of the application. When a license is not issued, a written explanation shall be given to the applicant.Article 26 Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License, and shall verify the certificates of qualified products.Distribution enterprises shall not distribute medical devices without registration certificates or certificates for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Medical institutions shall not use medical devices without registration, or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Article 27 Medical institutions shall not re-use medical devices labeled for single use, shall destroy them after use and establish a record, according to relevant provisions of the country.Article 28 The State shall establish a quality incident reporting system and a warning system of medical devices. Implementation details shall be stipulated by the drug regulatory authority under the State Council, in conjunction with the health authority and family planning authority under the State Council.Chapter IV Supervision of Medical DevicesArticle 29 The drug regulatory authorities of governments at county level and above shall appoint medical device monitors within their organization, who are responsible for the supervision and inspection of medical device manufacturing enterprises, distribution enterprises and medical institutions within their own administrative regions. When necessary, monitors may take product samples and ask for relevant materials according to the provisions promulgated by the drug regulatory authority under the State Council. Institutions and individuals concerned shall not decline cooperation or be deceitful in the monitoring process. The monitors shall be responsible to keep collected samples and materials confidential.Article 30 The State implements an accreditation system for the qualification of the testing institutions of medical devices. Only testing institutions accredited by the drug regulatory authority in conjunction with the quality and technical supervision authority under the State Council may conduct medical device test.Medical device testing institutions and their staff members shall keep strictly confidential all technical information provided by enterprises whose products are being tested, and shall not conduct or be involved in research and development, manufacture, distribution and technical consultation related to the devices tested.Article 31 For products having caused or which may potentially cause quality incidents, the drug regulatory authority of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.Article 32 The drug regulatory authority of the governments at provincial level and above shall revoke the registration certificates of medical devices of which safety and effectiveness can not be ensured. Medical devices whose registration certificates have been revoked shall not be manufactured, distributed and used. Those already produced or imported shall be dealt with by the drug regulatory authority of government at county level and above.Article 33 The drug regulatory authorities of the government of the municipality consisting of districts and above, which perform product registrations in violation of these regulations, shall be ordered by the drug regulatory authority under the state council to correct the violations within a defined period. For those not corrected within the period, the product registration certificates may be revoked and the events may be made public.Article 34 Advertisements of medical devices shall be reviewed and approved by the drug regulatory authority of governments at provincial level and above, and shall not be published, broadcasted, circulated or posted before the approval.The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory authority under the State Council or the drug regulatory authority of the governments of provinces, autonomous regions and municipalities directly under the Central Government.Chapter V PenaltiesArticle 35 In cases of manufacturing medical devices without product registration certificates, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and related illegal income. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times the total sum of the illegal income shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; in serious cases, the drug regulatory authorities of the governments at the provinces, autonomous regions and municipalities directly under the Central Government shall revoke the Medical Device Manufacturing Enterprise License; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 36 In cases of manufacturing class II and class III medical devices without a Medical Device Manufacturing Enterprise License, in violation of these regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 37 In cases of manufacturing medical devices not in conformity with national standards or professional standards for medical devices, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an warning, followed with an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the product registration certificates shall be revoked by the authorities originally issued the certificates; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 38 In cases of Distribution of class II and class III medical devices without a Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand yuan to RMB 20 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 39 In cases of distributing medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drugregulatory authority of governments at county level and above shall issue an order to stop the distribution, confiscate all of the illegally distributed products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the Medical Device Distributing Enterprise License shall be revoked by the authorities which originally issued the license; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 40 In cases where false certificates, documents, materials, or product samples are submitted in registration applications, or obtaining medical device registration certificates are obtained using other deceitful means, which violate provisions of these Regulations, the product registration certificates shall be revoked by the authorities which originally issued the certificates, and within a period of two years, other product registration applications of the violating enterprise shall not be accepted. Additionally, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; for enterprises already started manufacturing, all of the illegally manufactured products and their illegal incomes shall be confiscated; in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 41 Violation of Article 34 of these Regulations concerning provisions for advertisement of medical devices shall be dealt with by the industrial and commercial authority according to relevant laws and regulations of the country.Article 42 In cases of Medical institutions using medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violate provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction, launch a warning, and confiscate all of the illegally used products and illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed, and person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 43 In cases of medical institutions re-using devices for single use, or not destroying devices which should be destroyed, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 5 thousand to 30 thousand yuan; in serious cases, the medical institutions may be applied with a fine of RMB 30 thousand to 50 thousand yuan, and person(s) in charge and other directly responsible personnel be applied with disciplinary punishment; and in case crimes are committed, criminal liabilities shall be investigated and handled according to the law.Article 44 In cases in which medical institutions undertake clinical trials or clinical verifications of medicaldevices and provide false reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RM B 10 thousand to 30 thousand yuan；in serious cases, the qualification for clinical trial or clinical verification of medical devices shall be terminated, person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; an d in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 45 For cases in which testing institutions and their personnel are found to be conducting or involved in research and development, manufacturing, distribution and technical consultation of medical devices which are related to the testing, or establishing false testing reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 10 thousand to 30 thousand yuan; in serious cases, the qualification for testing shall be terminated by the drug regulatory authority under the State Council, person(s) in charge and other directly responsible personnel shall be receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to law.Article 46 In cases where personnel engaged in supervision and administration of medical devices abuse their power, pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of these Regulations, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled according to the law. For those not committing crimes, disciplinary punishment shall be applied according to the relevant regulations.Chapter VI Supplementary ProvisionsArticle 47 Provisions governing non-profitable contraceptive devices shall be formulated separately by the drug regulatory authority in conjunction with other relevant authorities under the State Council.Article 48 These Regulations shall come into force from April 1, 2000.。

新修订医疗器械监督管理条例新修订医疗器械监督管理条例第一章总则第一条为了规范医疗器械的监督管理工作，保障人民群众的生命安全和身体健康，根据《中华人民共和国立法法》等法律法规，制定本条例。

第二条本条例适合于在中华人民共和国境内开展医疗器械生产、经营、使用和管理活动的单位和个人，以及与医疗器械监督管理有关的其他机构和人员。

第三条医疗器械监督管理应当坚持预防为主、风险可控的原则，加强对医疗器械生产、经营、使用和管理环节的监督，提高医疗器械监管能力和水平，保障医疗器械的质量和安全。

第四条国家鼓励和支持医疗器械科研、创新和技术改造，促进医疗器械产业的发展，提升医疗器械技术水平和国际竞争力。

第五条医疗器械监督管理应当依法保护医患权益，加强对医疗器械安全的监督，提高公众对医疗器械安全的认知和保护能力。

第六条国家设立医疗器械监督管理部门，负责全国医疗器械监督管理工作。

各省、自治区、直辖市应当设立医疗器械监督管理机构，负责本行政区域内的医疗器械监督管理工作。

附件一：医疗器械分类目录附件二：医疗器械注册申请表格样本附件三：医疗器械监督抽查合格标准...本所涉及的法律名词及注释：1. 医疗器械：指人体表面或者体内，或者通过渗透至人体组织、器官等途径来预防、诊断、治疗、监测或者缓解疾病的设备、器具、仪器、材料或者其他物品，以及相关的软件。

2. 监督管理：指国家有关部门对医疗器械生产、经营、使用和管理过程进行监督和管理，包括许可、注册、备案、标准、抽查等方面的监督。

3. 医疗器械生产许可：指医疗器械生产企业依法取得的生产医疗器械的许可证书。

4. 医疗器械经营许可：指医疗器械经营企业依法取得的经营医疗器械的许可证书。

5. 医疗器械注册：指医疗器械生产企业或者进口医疗器械的申请人依法申请并取得的医疗器械注册证书。

最新医疗器械监督管理条例第一章总则第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。

第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。

第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。

国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

县级以上地方人民的政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。

县级以上地方人民的政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。

第四条国家对医疗器械按照风险程度实行分类管理。

第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。

国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。

制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。

医疗器械分类目录应当向社会公布。

第五条医疗器械的研制应当遵循安全、有效和节约的原则。

国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。

第六条医疗器械产品应当符合医疗器械强制性国家标准;尚无强制性国家标准的，应当符合医疗器械强制性行业标准。

一次性使用的医疗器械目录由国务院食品药品监督管理部门会同国务院卫生计生主管部门制定、调整并公布。

重复使用可以保证安全、有效的医疗器械，不列入一次性使用的医疗器械目录。

医疗器械监督管理条例(2017年修正)医疗器械监督管理条例（2017年修正）第一章总则第一条为了加强医疗器械监督管理，确保医疗器械安全有效和人民群众身体健康，根据《中华人民共和国医疗器械监督管理法》的规定，制定本条例。

第二条医疗器械监督管理的基本原则是：保证人民群众的生命安全和身体健康第一。

第三条本条例适用于医疗器械的生产、经营、使用、委托生产、进口、出口和广告宣传等活动。

第四条国家实行医疗器械分类管理制度。

第二章医疗器械的监督管理第五条市场监督管理部门负责医疗器械的监督管理工作，具体职责包括：（一）制定和组织实施医疗器械监督管理政策、法规和标准；（二）制定和组织实施医疗器械注册、备案、监督检查等制度；（三）组织对医疗器械生产、经营、使用等活动进行监督检查，发现问题及时采取监管措施；（四）组织和开展医疗器械有关的技术评价和质量检验工作；（五）处理医疗器械投诉和不良事件的汇报、调查和处理工作；（六）开展医疗器械监督管理的宣传教育和培训工作；（七）参与国际间医疗器械监督管理活动。

第六条医疗器械的注册、备案和变更由市场监督管理部门负责。

医疗器械注册必须通过相关法定机构的技术评价，并可依法对其进行专项审批。

第七条医疗器械的生产、经营必须取得医疗器械许可证。

市场监督管理部门应当会同有关部门从事医疗器械生产、经营活动的单位制定生产、经营规范，并组织实施。

第八条进口、出口医疗器械必须符合国家技术标准，有关进口、出口医疗器械的检验、检疫工作，由国务院有关部门负责。

第九条医疗器械的广告宣传必须真实、准确，不得含有虚假宣传和误导性内容。

医疗器械广告宣传发布前，须经过市场监督管理部门审查。

第十条医疗器械生产企业在国家明令禁止生产的医疗器械，不得生产、销售。

第十一条医疗器械进口企业应当具备相应的资质，从事医疗器械的进口业务。

第十二条医疗器械生产、经营单位应当建立医疗器械质量安全管理制度，加强质量管理和质量控制，保证医疗器械的质量安全。

Measures for the Supervision and Management of Medical Device OperationChapter I General PrinciplesArticle 1These measures are specially formulated to strengthen the supervision and management of medical device operation, standardize the operating behaviors of medical devices, and guarantee the safety and validity of medical devices in accordance with the Regulations on the Supervision and Administration of Medical Devices.Article 2 The operating activities and their supervision and management of the medical devices dealt with within the territory of the People's Republic of China should be governed by these measures.Article 3China Food and Drug Administration shall be in charge of the supervision and management of the medical device operation nationwide. The food and drug administration department above county level shall be responsible for the supervision and management on the medical device operation within respective jurisdiction.Higher-level food and drug administration department shall be responsible for directing and supervising the supervision and management on the medical device operation conducted by lower-level food and drug administration department.Article 4Classified management shall be implemented for medical device operation according to the risk level of medical device.The operation of Class I medical devices may be exempted from licensing and filing; filing management shall be implemented for the operation of Class II medical devices; and licensing management shall be implemented for the operation of Class III medical devices.Article 5China Food and Drug Administration shall formulate the good supply practice for medical devices and supervise the implementation.Article 6 Food and drug administration department should timely publish the information on the licensing and filing for medical device operation according to law. Applicant may inquire about the progress and results of examination and approval and the public may look up the examination and approval results.Chapter II Operation Licensing and Filing ManagementArticle 7 Applicant dealing with medical device operation should meet the following conditions:(I) Possess the quality management institution or quality management personnel appropriate to the operating scale and business scope; the quality management personnel should have the professional educational background or technical title in relevant disciplines recognized by the state;(II) Possess the operating and storage site appropriate to the operating scale and business scope;(III) Possess the storage conditions appropriate to the operating scale and business scope.Storeroom may not be set up in case of the storage fully entrusted to other medical device operating enterprise;(IV) Possess the quality management system appropriate to the medical devices operated;(V) Possess the capability of professional guidance, technical training and after-sales service appropriate to the medical devices operated, or provide technical support by relevant institution as agreed.The enterprises dealing with the operation of Class III medical devices should also have the computer information management system complying with the requirements of the GSP for medical devices to ensure the traceability of the products operated. The enterprises dealing with the operation of Class I and Class II medical devices are encouraged to establish the computer information management system complying with the requirements of the GSP for medical devices.Article 8 The operating enterprise dealing with the operation of Class III medical devices should submit its application for the food and drug administration department of the municipality with districts and submit the following materials:(I) Copies of business license and organization code certificate;(II) Copies of the ID cards, educational background or professional title certificates of legal representative, responsible person of enterprise, and quality director;(III) Explanation on the establishment of organizational structure and departments; (IV) Explanation on business scope and business practice;(V) Copies of the geological location map, floor plan and house ownership certificate leasing agreement (attached with house ownership certificate);(VI) List of operating facilities and equipment;(VII) List of documents including operating quality management system, working procedure, etc.;(VIII) Introduction of basic information of computer information management system and explanations on functions;(IX) Authorization certificate of agent;(X) Other evidential materials.Article 9 For the application for the licensing of the operation of Class III medical devices submitted by applicant, the food and drug administration department of themunicipality with districts may deal with respectively according to the following situations:(I) If the item applied is within the term of reference of the department and the application materials are complete and consistent with the legal form, the department should accept the application;(II) If the application materials are incomplete or not inconsistent with the legal form, the applicant shall be informed of all contents to be added and/corrected in one time either on site or within five (5) working days;(III) If the application materials have any error that can be corrected on the spot, the applicant should be allowed to make correction on the spot;(IV) If the item applied is not falling into the term of reference of the department, the department should immediately make the decision on denial to accept the application and inform the applicant to submit application to relevant administrative department.In case of acceptance or denial to accept the application for the licensing of medical device operation, the food and drug administration department of the municipality with districts should issue the Notice of Acceptance or Denial.Article 10 The food and drug administration department of the municipality with districts should examine and verify the application materials within thirty (30)working days from the date of acceptance and carry out on-site verification according to the requirements of the Good Supply Practice for medical devices. In case of rectification required, the rectification time will not be included in the examination and verification time.For those meeting specified conditions, the written decision on licensing shall be made according to laws and the License for Medical Device Operation shall be issued within ten (10) working days; for those not meeting specified conditions, if the written decision on denial is made, the reasons should be specified.Article 11If the application for the licensing of medical device operation directly relates to the major interest relationship between the applicant and others, food and drug administration department should inform the applicant and the interested party of the rights to apply for hearing enjoyable according to laws and regulations and the relevant provision of China Food and Drug Administration; while conducting examination of the licensing for medical device operation, food and drug administration department, if deems the application as the major licensing item relating to public interest, should announce to the public and hold a hearing.Article 12 In case of the operation of Class II medical devices, operating enterprise should file with the local food and drug administration department of municipality with districts, fill in the Class II Medical Device Operation Filing Form, and submit the materials specified in Article 8 of these measures (except for Item 8).Article 13 Food and drug administration department should verify the integrity of the materials submitted by enterprise on the spot; filing will be permitted for those complying with the provisions and issued with the certificate of filing for the operation of Class II medical devices.Article 14The food and drug administration department of the municipality with districts should carry out the on-the-spot verification on the operating enterprise of Class II medical device according to the requirements of the Good Supply Practice for medical devices within 3 months from the filing date of the medical device operating enterprise.Article 15 The valid period of the License for Medical Device Operation is five (5) years, which shall indicate such items as license number, name of enterprise, legal representative, responsible person of enterprise, residence, site of business operation,mode of operation, business scope, address of warehouse, issuing body, issuing date, valid period, etc.The certificate of filing for medical device operation should indicate such items as the number, name of enterprise,legal representative, responsible person of enterprise, residence, site of business operation, mode of operation, business scope, address of warehouse, filing department, filing date, etc.Article 16The change of the items in the License for Medical Device Operation may be classified into change of licensing item and change of registration item. Change of licensing items includes site of business operation, mode of operation, business scope, and address of warehouse.Change of registration items includes other items beyond aforesaid items.Article 17 In case of change of licensing items, the application for change of the License for Medical Device Operation shall be submitted to the original issuing department.The materials relating to the change of contents as specified in the provisions of Article 8 of these measures should be submitted.If warehouse is arranged across administrative regions, applicant should handle the filing with the food and drug administration department of the municipality with districts where the warehouse is located.The original issuing department should verify within fifteen (15) working days after receiving the application for change and make decision on permission for change or denial for change; if on-the-spot verification should be conducted according to the requirements of the Good Supply Practice for medical devices, the decision on permission for change or denial for change shall be made within thirty (30) days after receiving the application for change. In case of denial for permission, the reasons should be specified in written and the applicant should be informed. The number and valid period of the changed License for Medical Device Operation shall remain unchanged.Article 18For new independent site of business operation, medical device operation licensing or filing should be applied independently.Article 19 In case of change of registration items, medical device operating enterprise should timely handle the procedures for change with the food and drug administration department of the municipality with districts.Article 20 The medical device operating enterprise existed due to splitting and merger should apply for change of licensing according to the provisions of these measures; the medical device operating enterprise dissolved due to splitting and merger should apply for cancellation of the License for Medical Device Operation; and the medical device operating enterprise newly established due to splitting and merger should apply for handling the License for Medical Device Operation.Article 21Medical device registrant,filer or manufacturing enterprise selling medical devices at their residences or manufacturing site may not handle operation licensing or filing; in case of storing at other places and selling medical devices on the spot, they should handle the operation licensing or filing according to provisions.Article 22 If the valid period of the License for Medical Device Operation is extended upon expiration, medical device operating enterprise should submit the application for the extension of the License for Medical Device Operation with the original issuing department six months before the expiration of the valid period.Original issuing department should verify the application for extension according to the provisions in Article 10 of these measures; if necessary, conduct on-the-spot verification, and make the decision on whether to approve the extension before the expiration of the valid period of the License for Medical Device Operation. If the application for extension that meets the specified conditions is approved,the number of the extended License for Medical Device Operation shall remain unchanged. Those not complying with the specified conditions should be instructed to make rectification within specified time; if the specified conditions still fail to meet the specified conditions after rectification. The application for extension shall not be approved and the reasons should be specified in written. If no decision is made overdue, it will be regarded as the extension is approved.Article 23In case of any change to the filing items such as the name of enterprise, legal representative, responsible person of enterprise, residence,site of business operation, mode of operation, business scope, address of warehouse, etc. in the filing certificate of medical device operation, the filing should be changed in a timely manner.Article 24 In case that the License for Medical Device Operation is lost, medical device operating enterprise should immediately publish lost declaration on the media designated by the original issuing department. After 1 month after the lost declaration is published, the application for re-issuance of the certificate shall be submitted to the original issuing department. The original issuing department should timely re-issue the License for Medical Device Operation.The number and valid period of the re-issued License for Medical Device Operation shall be the same as the original certificate.Article 25 If the filing certificate for medical device operation is lost, medical device operating enterprise should immediately handle the procedures for re-issuance with the original filing department.Article 26 If medical device operating enterprise is investigated by food and drug administration department due to illegal business but the case has not been closed or receives the decision on administrative sanction, the food and drug administration department of the municipality with districts should terminate the licensing until the case is completed.Article 27In case that the certificate of medical device operating enterprise should be canceled according to the provisions of the laws and regulations or the valid period of the license has not expired but the enterprise proposes the cancellation with initiative, the food and drug administration department of the municipality with districts should cancel the License for Medical Device Operation according to laws and publish on website.Article 28The food and drug administration department of the municipality with districts should establish the licensing filing such as the issuance, extension, change, re-issuance,revocation, cancellation, etc. of the License for Medical Device Operation and filing information file of medical device operation.Article 29Any unit and individual should not forge,alter,buy and sell,lease and lend the License for Medical Device Operation and the filing certificate of medical device operation.Chapter III Operation Quality ManagementArticle 30Medical device operating enterprise should establish the operation management system covering the whole course of quality management according to the requirements of the Good Supply Practice for medical devices and properly keep the record, and ensure the operation conditions and operation behaviors to persistently comply with the requirements.Article 31Medical device operating enterprise should bear the legal responsibility for the medical device buying and selling behavior committed by the administrative office or sales person in the name of the enterprise. The sales personnel of the medical device operating enterprise selling medical device should have the letter of authorization affixed with the official seal of the enterprise. The letter of authorization should indicate the variety sold under authorization, region,and time limit and indicate the ID card number of the sales person.Article 32 Medical device operating enterprise should establish and execute the incoming inspection and recording system. The operating enterprise dealing with the wholesale business of Class II and Class III medical devices and the retail business of Class III medical devices should establish sales record system. The information ofincoming inspection record and sales record should be authentic, accurate, and complete.For the enterprise dealing with the wholesale business of medical devices, the records of purchase, storage, and sales should meet the requirements on traceability.Incoming inspection record and sales record should be kept for 2 years after the valid period of the medical device; if valid period is unavailable, the records shall be kept for no less than 5 years. The incoming inspection record and sales record of implantable medical devices should be kept permanently.Other medical device operating enterprises are encouraged to establish sales record system.Article 33Medical device operating enterprise should purchase medical devices from the manufacturing enterprise or operating enterprise with qualification. Medical device operating enterprise should agree on quality responsibility and after-sales service responsibility with supplier to ensure the safety use of medical devices after sales.The medical device operating enterprise agrees with supplier or appropriate institution that it will be responsible for the installation, maintenance, and technical training services of product may not establish the department dealing with technical training and after-sales service but should have appropriate management personnel.Article 34 Medical device operating enterprise should take effective measures to ensure the transportation and storage process of medical devices to comply with the requirements of the instructions for medical devices or labels and marking, and keep proper record to ensure the safety of medical device quality.If the instructions and label indicate that the medical devices should be stored at low temperature and in refrigeration, low-temperature, refrigeration facilities and equipment should be used for transportation and storage according to relevant provisions.Article 35If medical device operating enterprise entrusts other units to transport medical devices,the quality assurance capability of the medical devices transported by carrier should be assessed and evaluated,clearly defining the quality responsibility during the transportation to ensure the quality safety during transportation.Article 36 Medical device operating enterprise, if provides storage and delivery services to other manufacturing and operating enterprises of medical devices, should sign written agreement with client, defining the rights and obligations of both parties, has the equipment and facilities appropriate to the conditions for product storage and delivery and scale,and the computer information management platform and technical means for conducting the real-time electronic data exchange and realizing the whole-course traceability of the product operation with client.Article 37 The operating enterprise dealing with the wholesale business of medical devices should sell medical devices to the operating enterprise or user unit with qualification.Article 38 Medical device operating enterprise should arrange full-time or part-time personnel in charge of after-sales management,find out the reasons for the quality problem complained by customer, take effective measures for timely treatment and feedback, and properly keep the record; if necessary, inform the supplier and the medical device manufacturing enterprise.Article 39 If medical device operating enterprise has no the conditions for the original operation licensing or does not comply with the filing information and cannot be contacted, after publication by the original issuing or filing department, the License for Medical Device Operation should be canceled according to laws or indicated in the filing information of Class II medical device operation, and announced to the public.Article 40 The operating enterprise of Class III medical device should establish quality management self-inspection system and conduct all-item self-inspection according to the requirements of the Good Supply Practice for medical devices, and submit annual self-inspection report to the local food and drug administration department of the municipality with districts at the end of each year.Article 41 The operating enterprise of Class III medical device resumes business after self-close-down for more than one year, it should report to the food and drug administration department of the municipality with districts in written in advance; the business should not resumed until being inspected as complying with requirements.Article 42 Medical device operating enterprise should not operate the medical devices that are not registered or filed, without qualified certificate, and out-of-date, invalid, and washed out.Article 43 In case of major quality accident occurred on the medical device operated by medical device operating enterprise, it should report to the local food and drug administration department of the province, autonomous region or municipality directly under the central government within 24 hours, which will immediately report to China Food and Drug Administration.Chapter IV Supervision and ManagementArticle 44Food and drug administration department should regularly or irregularly conduct supervision and inspection on the compliance of medical device operating enterprise with the requirements of the Good Supply Practice and supervise and urge enterprises to standardize operating activities. The annual self-inspection report on the all-item self-inspection conducted by the operating enterprise of Class III medical devices according to the requirements of the Good Supply Practice for medical devices should be examined; if necessary, field inspection should be conducted.Article 45The food and drug administration department of province, autonomous region or municipality directly under the central government should compile the supervision and inspection plan for the medical device operating enterprises within respective administrative region and supervise the implementation. The food and drug administration department of municipality with districts should formulate the supervision focus, inspection frequency and coverage of the medical device manufacturing enterprise within respective administration region and organize the implementation.Article 46 Food and drug administration department organizing supervision and inspection should formulate inspection scheme,clearly defining the inspection criteria, record the inspection conditions on the spot according to facts, and inform the inspected enterprise of the inspection results in written. If rectification is required, the rectification contents and rectification time limit should be defined and follow-up inspection should be implemented.Article 47 Food and drug administration department should strengthen the random inspection on medical devices.The food and drug administration department above the level of province should timely publish medical device quality announcement according to the conclusions of the random inspection.Article 48 In any of the following circumstances, food and drug administration department should strengthen field inspection:(I) Severe problems existed in the supervision and inspection in last year;(II) Subject to administrative penalty due to violation of relevant laws and regulations; (III) Class III medical device operating enterprise newly established;(IV) Other circumstances deemed by food and drug administration department as necessary to conduct field inspection.Article 49 Food and drug administration department should establish the routine supervision and management system for medical device operation and strengthen the routine supervision and inspection on medical device operating enterprises.Article 50Unannounced inspection may be implemented by food and drug administration department on the medical device operating enterprise existed with potential safety hazard of product complained and reported or indicated by other information and found out in routine supervision and inspection or the medical device operating enterprise with bad behavior record.Article 51 In any of the following circumstances, food and drug administration department may question the responsibility of the legal representative or responsible person of medical device operating enterprise.(I) Severe potential safety hazard existed in operation;(II) The product operated has been reported or complained or exposed by media for several times due to quality problem;(III) The credit rating is evaluated as the enterprise with bad credit; and(IV) Other circumstances deemed by food and drug administration department as necessary to question the responsibility.Article 52 Food and drug administration department should establish the archives for the supervision and management on medical device operating enterprise, record licensing and filing information, results of routine supervision and inspection,investigation and treatment of illegal act, etc.,and implement focused supervision and management on the medical device operating enterprise with bad credit record.Chapter V Legal ResponsibilityArticle 53In any of the following circumstance, the food and drug administration department above the level of county shall be instructed to make correction within time limit and warned; if the medical device operating enterprise refuses to make correction, a fine above RMB 5,000 but below RMB 20,000 shall be imposed;(I) Medical device operating enterprise fails to handle the change of registration items according to the provisions of these measures;(II) Medical device operating enterprise dispatching sales personnel to sell medical devices fails to provide the letter of authorization according to the requirements of these measures; and(III) The operating enterprise of Class III medical devices fails to submit annual self-inspection report to food and drug administration department before the end of each year.Article 54 In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and a fine above RMB 10,000 but below RMB 30,000 shall be imposed:(I)The business conditions of medical device operating enterprise have changed and no longer complied with the requirements of the Good Supply Practice for medical device but the enterprise has not make rectification according to provisions;(II) Medical device operating enterprise changed site of business operation or address of warehouse and expanded business scope without authorization or set up warehouses arbitrarily;(III) The operating enterprise dealing with he wholesale business of medical devices sells medical devices to the operating enterprise or user unit without qualification; and (IV)Medical device operating enterprise purchases medical devices from the manufacturing and operating enterprise without qualification.Article 55The enterprise deals with medical device operating activities without permission or fails to handle the procedures for extension according to laws but still deals with medical device operation after the valid period of the License for Medical Device Operation expires shall be punished according to the provisions in Article 63 of the Regulations on the Supervision and Management of Medical Devices.Article 56The enterprise providing false information or obtaining the License for Medical Device Operation with other deception means shall be punished according to the provisions in Article 64 of the Regulations on the Supervision and Management of Medical Devices.Article 57The enterprise forging, altering, buying and selling, leasing or lending the License for Medical Device Operation shall be punished according to the provisions in Article 64 of the Regulations on the Supervision and Management of Medical Devices.If any enterprise forges, alters, buys and sells, leases or lends the filing certificate for medical device operation, it shall be instructed to make correction by the food and drug administration department above the level of county and a fine below RMB 10,000 shall be imposed.Article 58The enterprise failing to file according to the provisions of these measures or providing false information during filing shall be punished according to the provisions in Article 65 of the Regulations on the Supervision and Management of Medical Devices.Article 59In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and be punished according to the provisions in Article 66 of the Regulations on the Supervision and Management of Medical Devices:(I) Operate the medical devices not complying with the compulsory standard or not complying with the technical requirements of the products registered or filed;(II) Operate the medical devices without qualified certificate, out of date, invalid and washed out;(III) Still refused to stop the operation of medical devices after being instructed to stop the business by food and drug administration department.Article 60In any of the following circumstances, the enterprise shall be instructed to make correction by the food and drug administration department above the level of county and be punished according to the provisions in Article 67 of the Regulations on the Supervision and Management of Medical Devices:(I) The instructions and labels for the medical devices operated do not comply with relevant provisions; and(II) Failure to transport and store medical devices according the instructions and labels and marking of medical devices.。

医疗器械监督管理条例（2020年修订）文章属性•【制定机关】国务院•【公布日期】2021.02.09•【文号】中华人民共和国国务院令第739号•【施行日期】2021.06.01•【效力等级】行政法规•【时效性】现行有效•【主题分类】药政管理正文中华人民共和国国务院令第739号《医疗器械监督管理条例》已经2020年12月21日国务院第119次常务会议修订通过，现予公布，自2021年6月1日起施行。

总理李克强2021年2月9日医疗器械监督管理条例（2000年1月4日中华人民共和国国务院令第276号公布2014年2月12日国务院第39次常务会议修订通过根据2017年5月4日《国务院关于修改〈医疗器械监督管理条例〉的决定》修订2020年12月21日国务院第119次常务会议修订通过）第一章总则第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，促进医疗器械产业发展，制定本条例。

第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，适用本条例。

第三条国务院药品监督管理部门负责全国医疗器械监督管理工作。

国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

第四条县级以上地方人民政府应当加强对本行政区域的医疗器械监督管理工作的领导，组织协调本行政区域内的医疗器械监督管理工作以及突发事件应对工作，加强医疗器械监督管理能力建设，为医疗器械安全工作提供保障。

县级以上地方人民政府负责药品监督管理的部门负责本行政区域的医疗器械监督管理工作。

县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

第五条医疗器械监督管理遵循风险管理、全程管控、科学监管、社会共治的原则。

第六条国家对医疗器械按照风险程度实行分类管理。

第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

Regulations for the Supervision and Management of Medical DevicesDecree of the State Council of the People’s Republic of ChinaNo. 650The Regulations for the Supervision and Management of Medical Devices, revised at the 39th executive meeting of the Stata Council on February 12, 2014, is hereby promulgated and shall go into effect as of June 1, 2014.Premier: Li KeqiangMarch 7, 2014Regulations for the Supervision and Management of Medical Devices(Promulgated as the Decree of the State Council of the People’s Republic of China No. 276 on January 4, 2000, and revised at the 39th executive meeting of the Stata Council on February 12,2014.)Chapter I General ProvisionsArticle 1 The Regulations are hereby formulated with a view to guaranteeing the safety and effectiveness of medical devices and protecting human health and life safety.Article 2All units or individuals engaged in the research and development, production, distribution, use, supervision andmanagement of medical devices within the territory of the People's Republic of China shall comply with the Regulation.Article 3The food and drug supervision and management department of the State Council shall be responsible for the supervision and management of national medical devices. Relevant departments of the State Council shall be responsible for the supervision and management relating to medical devices within respective term of reference.The food and drug supervision and management department of the local people’s government above the level of county shall be responsible for the supervision and management of medical devices within respective administrative region. Relevant departments of the local people’s governments above the level of county shall be responsible for the supervision and management relating to medical devices within respective term of reference.The food and drug supervision and management department of the State Council shall support the relevant departments of the State Council in the implementation of the national industrial plans and policies on medical devices.Article 4 The State shall implement classified management on medical devices based on the degree of risk.Class I Medical Devices are those with lower degree of risk for which the safety and effectiveness can be ensured through routine management;Class II Medical Devices are those with medium degree of risk for which further control is required to ensure their safety and effectivenessClass III Medical Devices are those with higher degree of riskwhich must be strictly controlled in respect to safety and effectiveness.Evaluation on degree of risk should take into account the anticipated purpose, structural characteristics, usage, and other factors of medical devices.The food and drug supervision and management department of the State Council shall be responsible for formulating the classification rules and classified catalog of medical devices, conduct timely analysis and evaluation on the change of product risk according to the production, distribution, and use of the medical devices, and adjust classified catalog. When formulating and adjusting the classified catalog, the food and drug supervision and management department of the State Council shall fully listen to the opinions of the medical device manufacturing and operating enterprises, using units, and industrial organizations, and consulting international classification practices of medical devices. The classified catalog should be made public.Article 5 The R&D of medical devices shall be based on the principle of safety, effectiveness and practicing economy. The State while giving play to the role of market mechanism encourages the research and development and innovation of medical devices, boosts the application and generalization of new technology of medical devices, and promotes the development of medical device industry.Article 6 Medical device products shall comply with the compulsory national standard for medical devices; if the compulsory national standard is unavailable; comply with the compulsory industrial standard for medical devices.The catalog of disposable medical devices shall be formulated,adjusted and published by the food and drug supervision and management department of the State Council together with the competent health and family planning department of the State Council.Medical devices that can guarantee its safety and effectiveness when reused shall not be included in the catalog. For medical devices that can guarantee its safety and effectiveness when reused after improvements in its design, production process and sterilization technology, etc., they shall be ruled out from the catalog.Article 7 The medical devices industrial organization should strengthen industrial self-discipline, promote credit system construction, urge enterprises to conduct production and operation activities according to law, and guide enterprises to be honest and trustworthy.Chapter II Registration and Filing of Medical DeviceProductsArticle 8 Product filing management shall be implemented on Class I medical devices. Product registration management shall be implemented on Class II and Class III medical devices.Article 9 The following materials should be submitted for the filing of Class I medical device products and application for the registration of Class II and Class III medical device products.(I)Product risk analysis materials;(II)Product technical requirements;(III)P roduct inspection report;(IV)Clinical evaluation materials;(V)Product instruction and label sample;(VI)Quality management system documents related to product research & manufacture and production;(VII)O ther materials necessary for demonstrating the safety and effectiveness of the medical device.The registration applicant and filing applicant of medical devices shall be responsible for the authenticity of the materials submitted.Article 10 For the filing of Class I medical device product, the filing applicant shall submit filing materials to the food and drug supervision and management department of the people’s government of the municipality established with districts; in which, product inspection report may be the self-inspection report of the filing applicant; clinical evaluation materials exclude clinical trial report but may be the materials demonstrating the safety and effectiveness through references and the data obtained from the clinical application of similar products.The overseas manufacturing enterprise exporting Class I medical device to the territory of the People’s Republic of China shall, through its representative office established within the territory of the People’s Republic of China or the business entity designated within the territory of the People’s Republic of China as the agent, submit filing materials and the evidential documents approved by the competent department of the county (region) where the filing applicant is located for marketing of the medical device to the food and drug supervision and management department of the State Council.In case of any change to the matters specified in the filing materials, filing applicant should apply for the filing ofchange with the original filing department.Article 11 For the application for the registration of Class II medical device products, registration applicant should submit registration materials to the food and drug supervision and management department of the people’s government of the province, autonomous region, or municipality directly under the central government where the applicant is located. For the application for registration of Class III medical device products, registration applicant should submit registration materials to the food and drug supervision and management department of the State Council.Overseas manufacturing enterprise exporting Class II and Class III medical devices to the territory of the People’s Republic of China, should through its representative office established within the territory of the People’s Republic of China or the business entity designated within the territory of the People’s Republic of China as its agent, submit registration materials and the evidential documents approved by the competent department of the county (region) where the registration applicant is located for marketing of the medical device to the food and drug supervision and management department of the State Council.The product inspection report in the registration materials of Class I and Class II medical device products should be the inspection report issued by medical device inspection agency; clinical evaluation materials should include clinical trial report, except for the medical devices exempted from clinical trial according to the Article 17 in this Regulation.Article 12The food and drug supervision and management department accepting registration application shall put forward the application materials to technical evaluationinstitution within 3 working days after the date of acceptance. Technical evaluation institution should complete the technical evaluation and then submit evaluation opinion to the food and drug supervision and management department.Article 13The food and drug supervision and management department accepting registration application should make decision within 20 working days after receiving the evaluation opinion. For those complying with the requirements on safety and effectiveness, registration is approved and the Medical Device Registration Certificate shall be issued; for those not complying with the requirements, the registration shall not be approved and the reasons shall be specified in written.When the food and drug supervision and management department of the State Council organizes the technical evaluation on imported medical devices, if it deems necessary to inspect the quality management system, the food and drug supervision and management department of the State Council shall organize the inspection technical institution of quality management system to conduct the inspection on the quality management system.Article 14 In case that substantial change takes place on the design, raw materials, production process, scope of application, usage, etc. of the Class II and Class III medical device products already registered and possibly affect the safety and effectiveness of the medical device, the registration applicant shall handle the procedure for change of registration with original registration department; if non-substantial change occurs and will not affect the safety and effectiveness of the medical device, the registration applicant shall put the change on record with the original registration department.Article 15The valid period of the Medical DeviceRegistration Certificate is 5 years. If the registration shall be renewed upon the expiration of the valid period, applicant should submit the application for renewal of registration with the original registration department within 6 months before the expiration of the valid period.Except for the circumstances as specified in Item 3 of this Article, the food and drug supervision and management department receiving the application for renewing registration should made the decision on approval for renewal before the expiration of the valid period of the registration certificate; if no decision is made overdue, it shall be considered as approved for renewal.In case of any of the following circumstances, the renewal of registration shall not be approved:(I)Registration applicant fails to put forward theapplication for renewing registration within specified time;(II)The compulsory standard for medical devices has been revised and the medical device cannot meet new requirements.(III)N o formalities about the issues stated in the Medical Device Registration Certificate are completed within specified time for the medical devices available to the rare diseases and public emergencies.Article 16 For the medical device newly developed but not listed in the classified catalog, applicant may directly apply for registration according to the provisions on the registration of Class III medical device products of the Regulations or determine the product class according to classification rules and apply for registration or filingaccording to the provisions of the Regulations after applying for class verification with the food and drug supervision and management department of the State Council.For directly applying for the registration of Class III medical device products, the food and drug supervision and management department of the State Council shall determine the class according to the degree of risk and timely include the medical device approved for registration into classified catalog. For applying for class verification, the food and drug supervision and management department of the State Council shall determine the class of the medical device and inform the applicant within 20 working days after the date of acceptance.Article 17The clinical trial is not required for filing Class I medical device. The clinical trial shall be conducted for registration of Class II and Class III medical device; however, in any of the following circumstances, the clinical trial may be exempted:(I)Medical device with definite operating principle, maturedesign and production process; same type of marketed medical device has been in clinical use for many years without severe adverse events and without change of conventional intended use(II)The safety and effectiveness of the medical device can be proved through non-clinical evaluation;(III)T he safety and effectiveness of the medical device can be proved through data analysis and evaluation from clinical trial or clinical application on the same type of medical device.The [Clinical Trial Exemption Catalog of Medical Device] shall be established, adjusted and published by CFDA.Article 18The clinical trial of medical device shall be conducted in the clinical trial institution with qualification according to the requirements of the Good Clinical Practice for Medical Device and filed with the food and drug supervision and management department of the people’s government of the province, autonomous region, and municipality directly under the central government where the applicant of the clinical trial is located. The food and drug supervision and management department accepting the filing of the clinical trial shall notify the filing situation to the food and drug supervision and management department and the competent department of health and family planning at the same level where the clinical trial institution is located.The conditions for the verification of the qualification of medical device clinical trial institution and the Good Clinical Practice for the clinical trial shall be formulated and published by the food and drug supervision and management department of the State Council together with the competent health and family planning department of the State Council; medical device clinical trial institution shall be verified and published by the food and drug supervision and management department of the State Council together with the competent health and family planning department of the State Council.Article 19The clinical trial of Class III medical devices with highly risky to human body shall be approved by the food and drug supervision and management department of the State Council. The catalog of the Class III medical devices that the clinical trial is highly risky to human body shall be formulated, adjusted, and published by the food and drug supervision and management department of the State Council.During examination and approval of the clinical trial, the foodand drug supervision and management department of the State Council shall conduct comprehensive analysis on the conditions such as the equipment, professionals, etc. of the institution undertaking the clinical trial of the medical devices, the degree of risk of the medical device, clinical trial protocol, clinical benefit and risk comparative analysis report, etc. The clinical trial approved shall be notified to the clinical trial applicant and the food and drug supervision and management department of the people’s government of the province, autonomous region, and municipality directly under the central government and the competent health and family planning department where the clinical trial institution is located.Chapter III Production of Medical DevicesArticle 20Enterprises engaging in the manufacturing activities of medical devices shall meet the following conditions:(I)Production site, environmental conditions, production equipment,and professional technical personnel appropriate to the medical devices manufactured;(II)Institution undertaking the quality inspection on the medical devices manufacturer or professional inspection personnel and inspection equipment;(III)Management system guaranteeing the quality of the medical devices;(IV)After-sales service capability appropriate to the medical devices manufactured;(V)Other requirements specified by product design and production process documents.Article 21The manufacturing enterprise engaging in the manufacturing of Class I medical devices shall put on record and submit the evidential materials specified by the provisionsof Article 20 of the Regulations with the food and drug supervision and management department of the municipal people’s government established with districts.Article 22 The manufacturing enterprise engaging in the manufacturing of Class II and Class III medical devices shall apply for production permit with the food and drug supervision and management department of the people’s government of the province, autonomous region or municipality directly under the central government where it is located and submit the evidential materials specified in Article 20 of the Regulations and the registration certificate of the medical device manufactured.The food and drug supervision and management department accepting the application for production permit shall examine the application materials within 30 working days from the date of acceptance and conduct examination according to the requirements of the Good Manufacturing Practice for Medical Devices formulated by the food and drug supervision and management department of the State Council. For those complying with the conditions, the application shall be approved and the Medical Device Manufacturing License shall be issued; for those not complying with the specified conditions, the application shall not be approved and the reasons shall be specified in written.The valid period of the Medical Device Manufacturing License is 5 years. If renewal is required upon the expiration of the valid period, the procedures for the renewal shall be handled according to the provisions on administrative licensing.Article 23The Good Manufacturing Practice for Medical Devices shall clearly stipulate the matters affecting the safety and effectiveness such as the design and development ofmedical devices, production equipment and conditions, procurement of raw materials, production process control, enterprise institutional setting, staffing, etc.Article 24 Medical device manufacturing enterprise shall establish perfect quality management system appropriate to the medical device manufacturing and guarantee the effective operation according to the requirements of the Good Manufacturing Practice for medical devices; strictly organize production according to the registered or filed product technical requirements and ensure the medical devices manufactured to comply with the compulsory standard and the registered or filed product technical requirements.Medical device manufacturing enterprise shall conduct self-inspection according to the operation of the quality management system regularly and submit self-inspection report to the food and drug supervision and management department of the people’s government of the province, autonomous region, or municipality directly under the central government where the enterprise is located.Article 25 If the production conditions of the medical device manufacturing enterprise change and no longer comply with the requirements of the Good Manufacturing Practice for medical devices any more, medical device manufacturing enterprise shall immediately take rectification measures; if the safety and effectiveness of the medical device may be affected, the medical device manufacturing enterprise shall immediately stop its manufacturing activities and report to the food and drug supervision and management department of the people’s government at the level of prefecture or county.Article 26 Medical devices shall use generic names. Generic name shall comply with the naming rules for medical devicesformulated by the food and drug supervision and management department of the State Council.Article 27Medical devices shall have instructions and labels. The contents of the instructions and labels should be consistent with the relevant contents registered or filed.The following matters shall be indicated on the instructions and labels for medical devices:(I)Generic name, model, and specification;(II)Name and domicile of manufacturing enterprise, manufacturing address and contact;(III)N umber of product technical requirements;(IV)Production date and service life or expiry date;(V)Product performance, main structure, and scope of application;(VI)Contraindication, matters needing attention, and other contents needing warning or promoting;(VII)I nstructions or illustrations for installation and operation;(VIII)Maintenance and repair method, special storage conditions and methods;(IX)Other contents to be indicated as specified by product technical requirements.Class II and Class III medical devices should be clearly indicated with the number of the Medical Device Registration Certificate, and the name, address and contact of medical device registration applicant.The medical device to be used by individual consumer shall have the special instructions for safe use.Article 28If medical device is manufactured under authorization, the entrusting party shall be responsible for the quality of the medical device manufactured under authorization. The entrusted party should be the medical device manufacturing enterprise complying with the provisions of the Regulations and with appropriate production conditions. The entrusting party should strengthen the management on the manufacturing behavior of the entrusted party to ensure the entrusted party to manufacture according to the statutory requirements.The implantable medical devices with high risks shall not be manufactured under authorization, detailed catalog of which shall be formulated, adjusted and published by the food and drug supervision and management department of the State Council.Chapter IV Operation and Use of Medical DevicesArticle 29The enterprise engaging in the operating activities of medical devices should have the operating place and storage conditions appropriate to the operating scale and operating range and the quality management system and quality management institution or personnel appropriate to the medical devices operated.Article 30 The operating enterprise engaging in the operation of Class II medical devices should put on record with the food and drug supervision and management department of the people’s republic of China of the municipality established with districts where the operating enterprise is located and submit the evidential materials meeting the conditions as specifiedin Article 29 of the Regulations.Article 31 The operating enterprise engaging in the operation of Class III medical devices shall apply for operation permit with the food and drug supervision and management department of the people’s government at the level of municipality established with districts and submit the evidential materials on the conditions specified in Article 29 of the Regulations.The food and drug supervision and management department accepting the application for operation permit shall conduct examination within 30 working days after the date of acceptance; if necessary, organize inspection. For those meeting specified conditions, the application will be approved and the Medical Device Operating Permit shall be issued; for those not complying with the specified conditions, the application will not be approved and the reasons shall be specified in written.The valid period of the Medical Device Operating Permit is 5 years. If renewal is required upon the expiration of the valid period, the procedures for renewal shall be handled according to the provisions on administrative licensing.Article 32 Medical device operating enterprise and using unit purchasing medical devices should check the qualification of the supplier and the qualified evidential document of medical device, and establish the stock inspection and recording system. The operating enterprise engaging in the wholesale service of Class I and Class II medical devices and the retail business of Class III medical devices should also establish sales recoding system.The matters of recording include:(I)Name, model, specification, and quantity of medicaldevices;(II)Production batch number, valid period, and sale date of medical devices;(III)N ame of manufacturing enterprise;(IV)Name, address and contract of supplier or purchaser;(V)Contents such as the numbers of relevant evidential documents.Stock inspection record and sales record should be authentic and kept according to the time limit specified by the food and drug supervision and management department of the State Council. The state encourages the recording with advanced technical means.Article 33 The transportation and storage of medical devices should comply with the requirements of the instructions and labels of medical devices; in case of special requirements on temperature, humidity, and other environmental conditions, appropriate measures should be taken to ensure the safety and effectiveness of medical devices.Article 34 Medical device using unit should have the storage places and conditions appropriate to the variety and quantity of the medical devices in use.Medical device using unit should strengthen the technical training on working staff and use medical devices according to the requirements of product instructions, technical operating specifications, etc.Article 35For the medical devices intended for reuse, medical device using unit should disinfect and sterilize such medical devices after use in accordance with the regulations on sterilization and administration enacted by the competent health and family planning department of the State Council.Disposable medical devices shall not be reused; the medical devices used should be destroyed and recorded according to relevant national provisions.Article 36 In case of regular inspection, test, calibration, repair, and maintenance of medical devices, medical device using unit should conduct inspection, test, calibration, repair, and maintenance and maintain the record according to the requirements of product instructions, timely conduct analysis and evaluation, and ensure medical devices in good state and guarantee the quality of use; for large medical devices with longer service life, establish use record one by one, record the use, maintenance, transfer, actual time of use, and other contents. The storage life of record should not be less than 5 years after termination of the time limit of use of the medical device specified.Article 37 Medical device using unit shall properly keep the raw materials of Class III medical devices purchased and ensure the traceability of the information.If large medical devices and implantable and interventional medical devices are used, the name of the medical devices, key technical parameters, other information and other necessary information closely related to quality and safety shall be recorded in medical record and other relevant records.Article 38 If hidden problem is found existed on the medical devices in use, medical device using unit should immediately stop using, and inform manufacturing enterprise or other institutions responsible for the quality of product of overhaul; the medical device that still cannot meet the safety standard for use after overhaul should not be continuously used.Article 39Food and drug supervision and management department。

医疗器械监督管理条例第一章总则第一条目的和基本原则医疗器械监督管理条例（以下简称“条例”）的目的是加强对医疗器械的监督管理，保障人民群众的健康和生命安全。

本条例的基本原则是依法、科学、公正、透明，加强医疗器械的质量监督和安全管理，促进医疗器械行业的健康发展。

第二条适用范围本条例适用于我国境内生产、进口、销售、使用医疗器械的单位和个人，以及从事医疗器械监督管理工作的有关机构和人员。

第三条法律地位本条例是依据《中华人民共和国药品管理法》、《中华人民共和国医疗器械监督管理办法》等法律法规制定的具体规定。

第二章医疗器械监督管理机构第四条医疗器械监督管理机构的职责医疗器械监督管理机构负责统一管理、监督和执法医疗器械的生产、经营和使用，并负责制定医疗器械的注册、备案、监测、检验等相关规定。

第五条公布信息医疗器械监督管理机构应当公布医疗器械的注册、备案、质量监督和安全管理的信息，以及有关医疗器械的质量不良和安全事故的处理情况。

公布的信息应当及时、准确、完整。

第六条督促检查医疗器械监督管理机构有权对生产、经营、使用医疗器械的单位和个人进行检查，督促其遵守本条例和其他法律法规的规定。

第三章医疗器械的注册和备案第七条医疗器械的注册管理医疗器械应当依法经过注册才能销售和使用。

医疗器械注册应当遵循科学、公正、透明的原则，确保医疗器械的安全性与有效性。

第八条注册申请和审批申请医疗器械注册的企业或个人应当向医疗器械监督管理机构提交申请，并提供相关资料。

医疗器械监督管理机构应当依法对申请进行审批，并在规定的时间内给出审批结果。

第九条医疗器械的备案管理医疗器械备案是指对不需要进行注册的医疗器械进行管理的制度。

备案应当依法进行，并进行监督检查。

第四章医疗器械的质量监督和安全管理第十条质量监督医疗器械的生产企业应当建立和实施质量管理体系，确保医疗器械的质量符合相关标准和规定。

医疗器械监督管理机构有权对医疗器械的质量进行监督检查。

第十一条安全管理医疗器械的生产、经营和使用单位应当加强对医疗器械的安全管理，制定相应的安全管理措施，确保医疗器械的安全性和可靠性。

RegulationsRegulations for the Supervision and Administration ofMedical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices, ensuring their safety and effectiveness and protecting human health and life safety.Article 2 All units or individuals engaged in the research and development, production, distribution, use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation.Article 3 "Medical devices" as defined by these regulations refers to: any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions;3. Investigation, replacement or modification for anatomy or a physiological process;4. Control of conception.Article 4 The drug regulatory authority under the State Council is responsible for supervision and administration of medical devices nationwide. The drug administration of the localgovernment at county level and above is responsible for supervision and administration of medical devices in each administrative region. The drug regulatory authority under the State Council shall coordinate with other departments under the State Council, responsible for comprehensive economic administration, in the implementation of policies for the medical device industry.Article 5 The State shall classify medical devices and administer them based on this classificationClass I Medical Devices are those for which safety and effectiveness can be ensured through routine administration;Class II Medical Devices are those for which further control is required to ensure their safety and effectivenessClass III Medical Devices are those which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.The classification catalogue for medical devices shall be stipulated, adjusted and promulgated by the drug regulatory authority under the State Council, in accordance with classification principles after consulting with health authority under the State Council.Article 6 Medical devices produced and used for the purpose of providing concrete measuring values shall comply with the requirements of the metering law. The detailed product list shall be formulated and promulgated by the drug regulatory authority under the State Council, jointly with the metering authority.Chapter II The Administration of Medical DevicesArticle 7 The State encourages the research and development of new medical devices. "New medical devices" refer to the kind of brand new product varieties which have not been available in the domestic market, or for which the safety, effectiveness and product mechanism have not been recognized domestically.The clinical trials of new medical devices of Class II and Class III can be conducted only afterclinical trial approval by the relevant authority in accordance with the rules of the drug regulatory authority under State Council.New medical devices that have completed clinical trials and passed experts evaluation and review organized by the drug regulatory authority under State Council, shall receive a new product certificate after being approved by the same organization.Article 8 The State shall implement a product registration system for the manufacturing of medical devices.Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council.Clinical evaluation must be conducted for Class II and Class III medical devices before they are put into production.Article 9 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government are responsible for the inspection and approval of the clinical trial or verification of class II medical devices in their own administrative regions. The drug regulatory authority under the State Council is responsible for the inspection and approval of clinical trial or verification of class III medical devices.Clinical trial or verification shall be conducted in the medical institutions designated by the drug regulatory authorities of the government at provincial level and above. The medical institutions shall conduct the clinical trial or verification, in accordance with the related provisions of the drug regulatory authority under the State Council.The qualification of medical institutions engaged in the clinical trial or verification shall be certified by the drug regulatory authority, jointly with the health authority under the StateCouncil.Article 10 Medical institutions may develop medical devices to serve their own clinical needs, and use them within their own institution under the guidance of licensed medical practitioners.Class II medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority of the government at provincial level and above. Class III medical devices developed by medical institutions shall be inspected and approved by the drug regulatory authority under the State Council.Article 11 When importing medical devices into China for the first time, the agent of the imported device, should submit the instruction for use, quality standards, testing methods, other relevant information, product samples, and marketing authorization certificates issuedby the manufacturing countries (regions), for inspection and approval by the drug regulatory authority under the State Council, and receive an import product registration certificate before applying for customs formalities.Article 12 When applying for registration of medical devices, technical standards, testing report and other relevant information shall be submitted according to provisions of the drug regulatory authority under the State Council.The drug regulatory authority of the government of the municipality consisting of districts shall decide within 30 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 60 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.The drug regulatory authority under the State Council shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.Article 13 In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change.Article 14 The term of validity for the registration certificate of medical devices is four years. The holder of the certificate shall apply for re-registration within six months before the certificate expires.When the manufacturing of a medical device is stopped continuously for more than 2 years, its registration certificate is automatically invalidated.Article 15 Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available.National standards of medical devices shall be formulated jointly by the standardization authority and the drug regulatory authority under the State Council. Professional standards of medical devices shall be formulated by the drug regulatory authority under the State Council.Article 16 The instruction for use, label and package of medical devices shall comply with relevant standards or provisions in China.Article 17 The registration number of a medical device shall be marked on the product itself and the external package according to the provisions of the drug regulatory authority under the State Council.Article 18 The State implements a system of re-evaluation and obsolescence for medical devices, the details of which shall be formulated by drug regulatory authority under the State Council after consulting with other related authorities under the State Council.Chapter III Administration of Production, Distribution and Useof Medical DevicesArticle 19 Enterprises manufacturing medical devices shall meet the following conditions:1. Possess professional technical personnel required for the manufacture of its medicaldevices;2. Possess facility and environment required for the manufacture of its medical devices;3. Possess equipment required for the manufacture of its medical devices;4. Possess an establishment or personnel and equipment for quality testing required for the manufacture of its medical devices.Article 20 Establishment of manufacturing of class I medical devices, requires that the enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing manufacturing of class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Manufacturing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Manufacturing Enterprise License.The term of validity of the Medical Device Manufacturing Enterprise License is 5 years. Upon expiration, re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 21 Medical device manufacturing enterprises shall not start manufacturing products before obtaining the manufacturing enterprise license.Article 22 The State implements a mandatory safety certification system for certain class III medical devices. A specific product list shall be established by the drug regulatory authority under the State Council, jointly with the quality and technology supervision authority.Article 23 Enterprises distributing medical devices shall meet the following conditions:1. Possess appropriate facility(s) and environment for the kind of medical devices to be distributed;2. Possess appropriate quality inspection personnel for the kind of medical devices to be distributed;3. Possess adequate ability for technical training, maintenance and after-sales services for the kinds of medical devices to be distributed;Article 24 Establishing of distribution of class II and/or class III medical devices, requires thatthe enterprise file a record with the drug regulatory authority of provinces, autonomous regions or municipalities directly under the central government.Establishing an enterprise distributing class II and/or class III medical devices, requires inspection and approval by the drug regulatory authorities of the provinces, autonomous regions and municipalities directly under the central government, who will then issue a Medical Device Distributing Enterprise License. The industrial and commercial authority shall not issue a business license to enterprises which have not received a Medical Device Distributing Enterprise License.The term of validity of the Medical Device Distribution Enterprise License is 5 years. Upon expiration, re-inspection and license renewal shall be conducted. Implementation details shall be formulated by the drug regulatory authority under the State Council.Article 25 The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 30 working days whether the licenses for manufacturing or distributing enterprises of medical devices can be issued, counting from the date of acceptance of the application. When a license is not issued, a written explanation shall be given to the applicant.Article 26 Distribution enterprises and medical institutions shall purchase qualified medical devices from enterprises having a Medical Device Manufacturing Enterprise License or Medical Device Distribution Enterprise License, and shall verify the certificates of qualified products.Distribution enterprises shall not distribute medical devices without registration certificates or certificates for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Medical institutions shall not use medical devices without registration, or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete.Article 27 Medical institutions shall not re-use medical devices labeled for single use, shall destroy them after use and establish a record, according to relevant provisions of the country.Article 28 The State shall establish a quality incident reporting system and a warning systemof medical devices. Implementation details shall be stipulated by the drug regulatory authority under the State Council, in conjunction with the health authority and family planning authority under the State Council.Chapter IV Supervision of Medical DevicesArticle 29 The drug regulatory authorities of governments at county level and above shall appoint medical device monitors within their organization, who are responsible for the supervision and inspection of medical device manufacturing enterprises, distribution enterprises and medical institutions within their own administrative regions. When necessary, monitors may take product samples and ask for relevant materials according to the provisions promulgated by the drug regulatory authority under the State Council. Institutions and individuals concerned shall not decline cooperation or be deceitful in the monitoring process. The monitors shall be responsible to keep collected samples and materials confidential.Article 30 The State implements an accreditation system for the qualification of the testing institutions of medical devices. Only testing institutions accredited by the drug regulatory authority in conjunction with the quality and technical supervision authority under the State Council may conduct medical device test.Medical device testing institutions and their staff members shall keep strictly confidential all technical information provided by enterprises whose products are being tested, and shall not conduct or be involved in research and development, manufacture, distribution and technical consultation related to the devices tested.Article 31 For products having caused or which may potentially cause quality incidents, the drug regulatory authority of the governments at county level and above shall have the right to check, seal up and detain them together with materials related.Article 32 The drug regulatory authority of the governments at provincial level and above shall revoke the registration certificates of medical devices of which safety and effectiveness can not be ensured. Medical devices whose registration certificates have been revoked shall not be manufactured, distributed and used. Those already produced or imported shall be dealt with by the drug regulatory authority of government at county level and above.Article 33 The drug regulatory authorities of the government of the municipality consisting ofdistricts and above, which perform product registrations in violation of these regulations, shall be ordered by the drug regulatory authority under the state council to correct the violations within a defined period. For those not corrected within the period, the product registration certificates may be revoked and the events may be made public.Article 34 Advertisements of medical devices shall be reviewed and approved by the drug regulatory authority of governments at provincial level and above, and shall not be published, broadcasted, circulated or posted before the approval.The contents of the advertisements shall be based on the instruction for use approved by the drug regulatory authority under the State Council or the drug regulatory authority of the governments of provinces, autonomous regions and municipalities directly under the Central Government.Chapter V PenaltiesArticle 35 In cases of manufacturing medical devices without product registration certificates, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and related illegal income. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times the total sum of the illegal income shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; in serious cases, the drug regulatory authorities of the governments at the provinces, autonomous regions and municipalities directly under the Central Government shall revoke the Medical Device Manufacturing Enterprise License; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 36 In cases of manufacturing class II and class III medical devices without a Medical Device Manufacturing Enterprise License, in violation of these regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB10 thousand yuan to RMB30 thousand yuan shall be imposed; and in case crimes are committed, criminal liabilityshall be investigated and handled according to the law.Article 37 In cases of manufacturing medical devices not in conformity with national standards or professional standards for medical devices, in violation of provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an warning, followed with an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the product registration certificates shall be revoked by the authorities originally issued the certificates; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 38 In cases of Distribution of class II and class III medical devices without a Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the production, confiscate all of the illegally manufactured products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand yuan to RMB 20 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 39 In cases of distributing medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order to stop the distribution, confiscate all of the illegally distributed products and their illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed; in serious cases, the Medical Device Distributing EnterpriseLicense shall be revoked by the authorities which originally issued the license; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 40 In cases where false certificates, documents, materials, or product samples are submitted in registration applications, or obtaining medical device registration certificates are obtained using other deceitful means, which violate provisions of these Regulations, the product registration certificates shall be revoked by the authorities which originally issued the certificates, and within a period of two years, other product registration applications of the violating enterprise shall not be accepted. Additionally, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; for enterprises already started manufacturing, all of the illegally manufactured products and their illegal incomes shall be confiscated; in case the illegal incomes exceed RMB10 thousand yuan, a fine of 3 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB10 thousand yuan, a fine of RMB 10 thousand to 30 thousand yuan shall be imposed; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 41 Violation of Article 34 of these Regulations concerning provisions for advertisement of medical devices shall be dealt with by the industrial and commercial authority according to relevant laws and regulations of the country.Article 42 In cases of Medical institutions using medical devices without registration certificates or certificate for qualified products, or medical devices which are beyond their expiry dates, of compromised effectiveness, or obsolete, or purchasing medical devices from enterprises without Medical Device Manufacturing Enterprise License or Medical Device Distributing Enterprise License, which violate provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction, launch a warning, and confiscate all of the illegally used products and illegal incomes. Additionally, in case the illegal incomes exceed RMB 5 thousand yuan, a fine of 2 to 5 times of the total sum of the illegal incomes shall be imposed; in case there are no illegal incomes or the illegal incomes do not exceed RMB 5 thousand yuan, a fine of RMB 5 thousand to 20 thousand yuan shall be imposed, and person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 43 In cases of medical institutions re-using devices for single use, or not destroying devices which should be destroyed, which violates provisions of these Regulations, the drug regulatory authority of governments at county level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 5 thousand to 30 thousand yuan; in serious cases, the medical institutions may be applied with a fine of RMB 30 thousand to 50 thousand yuan, and person(s) in charge and other directly responsible personnel be applied with disciplinary punishment; and in case crimes are committed, criminal liabilities shall be investigated and handled according to the law.Article 44 In cases in which medical institutions undertake clinical trials or clinical verifications of medical devices and provide false reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RM B 10 thousand to 30 thousand yuan；in serious cases, the qualification for clinical trial or clinical verification of medical devices shall be terminated, person(s) in charge and other directly responsible personnel shall receive disciplinary punishment; an d in case crimes are committed, criminal liability shall be investigated and handled according to the law.Article 45 For cases in which testing institutions and their personnel are found to be conducting or involved in research and development, manufacturing, distribution and technical consultation of medical devices which are related to the testing, or establishing false testing reports, which violates provisions of these Regulations, the drug regulatory authority of governments at provincial level and above shall issue an order for correction and launch a warning, and may impose a fine of RMB 10 thousand to 30 thousand yuan; in serious cases, the qualification for testing shall be terminated by the drug regulatory authority under the State Council, person(s) in charge and other directly responsible personnel shall be receive disciplinary punishment; and in case crimes are committed, criminal liability shall be investigated and handled according to law.Article 46 In cases where personnel engaged in supervision and administration of medical devices abuse their power, pursue personal benefits by deceiving, or neglecting their duties, in violation of provisions of these Regulations, to the extent to which crimes are committed, criminal liabilities shall be investigated and handled according to the law. For those not committing crimes, disciplinary punishment shall be applied according to the relevant。

医疗器械监督管理条例(2014年修订)文章属性•【制定机关】国务院•【公布日期】2014.03.07•【文号】国务院令第650号•【施行日期】2014.06.01•【效力等级】行政法规•【时效性】已被修改•【主题分类】药政管理正文中华人民共和国国务院令（第650号）《医疗器械监督管理条例》已经2014年2月12日国务院第39次常务会议修订通过，现将修订后的《医疗器械监督管理条例》公布，自2014年6月1日起施行。

总理李克强2014年3月7日医疗器械监督管理条例（2000年1月4日中华人民共和国国务院令第276号公布2014年2月12日国务院第39次常务会议修订通过）第一章总则第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。

第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。

第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。

国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。

县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。

第四条国家对医疗器械按照风险程度实行分类管理。

第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。

国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。

制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。

《医疗器械监督管理条例》医疗器械监督管理条例第一章总则第一条目的和依据《医疗器械监督管理条例》（以下简称“条例”）的目的是加强对医疗器械的监督管理，保障医疗器械的安全有效使用，保护人民的生命健康，依据《中华人民共和国药品管理法》和其他相关法律、行政法规。

第二条适用范围条例适用于在中华人民共和国境内生产、销售、使用、进口及运输、维修、废弃医疗器械的活动，并适用于医疗器械的监督管理工作。

第二章医疗器械的监督管理机构第三条健康行政部门根据《中华人民共和国药品管理法》的规定，省、自治区、直辖市级人民政府卫生主管部门负责所辖地区医疗器械的监督管理工作。

第四条监督管理机构的职责健康行政部门负责以下工作：1. 制定或参与制定本地区医疗器械的标准；2. 受理和审批生产、销售、进口医疗器械许可申请；3. 开展医疗器械的监督检查和监测；4. 对生产、销售、进口医疗器械活动中的违法行为进行处罚或行政处分；5. 提供有关医疗器械监督管理的咨询和技术支持。

第三章医疗器械的生产许可和备案第五条生产许可和备案的范围医疗器械的生产必须依法取得生产许可或备案，具体范围按照国家药品监督管理部门的规定执行。

第六条生产许可和备案的程序申请医疗器械生产许可或备案的企业应当按照国家食品药品监督管理部门的规定提交申请材料并接受审查。

第七条生产许可和备案的期限国家食品药品监督管理部门应当在受理申请之日起90日内完成审核，并作出准予或不准予许可或备案的决定。

第四章医疗器械的进口和销售第八条进口医疗器械的许可进口医疗器械必须依法取得进口许可。

进口医疗器械许可的具体管理办法由国家食品药品监督管理部门制定。

第九条医疗器械的销售许可销售医疗器械必须依法取得销售许可。

销售医疗器械许可的管理办法由国家食品药品监督管理部门制定。

第五章医疗器械的使用和废弃第十条医疗机构和临床试验单位的管理医疗机构和临床试验单位应当按照规定，建立医疗器械使用和管理制度，加强医疗器械的使用管理和质量控制。

RegulationsRegulations for the Supervision and Administration ofMedical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices， ensuring their safety and effectiveness and protecting human health and life safety。

Article 2 All units or individuals engaged in the research and development， production, distribution, use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation.Article 3 ”Medical devices" as defined by these regulations refers to： any instrument，apparatus, appliance, material, or other article whether used alone or in combination，including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology， immunology or metabolism, but which may be assisted in its function by such means； the use of which is to achieve the following intended objectives:1. Diagnosis, prevention, monitoring, treatment or alleviation of disease；2。

《淇疗Eft盘ft计代歩例》试趕用祥*《医疗器械监督管理条例》（国务院令第650号）2014年03月07日发布第四章医疗器械经营与使用第二十九条从事医疗器械经营活动,应当有与经营规模和经营范用相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。

第三十条从事第二类医疗器械经营的，由经营企业向所在地设区的市级人民政府食品药品监督管理部门备案并提交其符合本条例第二十九条规定条件的证明资料。

第三十一条从事第三类医疗器械经营的，经营企业应当向所在地设区的市级人民政府食品药品监督管理部门申请经营许可并提交其符合本条例第二十九条规宦条件的证明资料。

受理经营许可申请的食品药品监督管理部门应当自受理之日起30个工作日内进行审查, 必要时组织核查。

对符合规定条件的，准予许可并发给医疗器械经营许可证；对不符合规圮条件的，不予许可并书而说明理由。

医疗器械经营许可证有效期为5年。

有效期届满需要延续的，依照有关行政许可的法律规定办理延续手续。

第三十二条医疗器械经营企业、使用单位购进医疗器械，应当査验供货者的资质和医疗器械的合格证明文件，建立进货査验记录制度。

从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业，还应当建立销售记录制度。

记录事项包括：（-）医疗器械的名称、型号、规格、数虽:；（二）医疗器械的生产批号、有效期、销售日期：（三）生产企业的名称；（四）供货者或者购货者的名称、地址及联系方式；（五）相关许可证明文件编号等。

进货査验记录和销售记录应当貞•实，并按照国务院食品药品监督管理部门规左的期限予以保存。

国家鼓励采用先进技术手段进行记录。

第三十三条运输、贮存医疗器械,应当符合医疗器械说明书和标签标示的要求:对温度、湿度等环境条件有特殊要求的，应当采取相应措施，保证医疗器械的安全、有效。

第三十四条医疗器械使用单位应当有与在用医疗器械品种、数量相适应的贮存场所和条件。

医疗器械监督管理条例（2000年1月4日国务院令第276号公布；2014年3月7日国务院令第650号修订;2017年5月4日务院令第680号《国务院关于修改〈医疗器械监督管理条例〉的决定》修正）第一章总则第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。

第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。

第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。

国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。

县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。

第四条国家对医疗器械按照风险程度实行分类管理。

第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。

国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。

制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。

医疗器械分类目录应当向社会公布。

第五条医疗器械的研制应当遵循安全、有效和节约的原则。

国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。

第六条医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。

医疗器械监督管理条例（2000年1月4日中华人民共和国国务院令第276号公布2014年2月12日国务院第39次常务会议修订通过根据2017年5月4日《国务院关于修改<医疗器械监督管理条例>的决定》修订）第一章总则第一条为了保证医疗器械的安全、有效，保障人体健康和生命安全，制定本条例。

第二条在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理，应当遵守本条例。

第三条国务院食品药品监督管理部门负责全国医疗器械监督管理工作。

国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

县级以上地方人民政府食品药品监督管理部门负责本行政区域的医疗器械监督管理工作。

县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。

国务院食品药品监督管理部门应当配合国务院有关部门，贯彻实施国家医疗器械产业规划和政策。

第四条国家对医疗器械按照风险程度实行分类管理。

第一类是风险程度低，实行常规管理可以保证其安全、有效的医疗器械。

第二类是具有中度风险，需要严格控制管理以保证其安全、有效的医疗器械。

第三类是具有较高风险，需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。

评价医疗器械风险程度，应当考虑医疗器械的预期目的、结构特征、使用方法等因素。

国务院食品药品监督管理部门负责制定医疗器械的分类规则和分类目录，并根据医疗器械生产、经营、使用情况，及时对医疗器械的风险变化进行分析、评价，对分类目录进行调整。

制定、调整分类目录，应当充分听取医疗器械生产经营企业以及使用单位、行业组织的意见，并参考国际医疗器械分类实践。

医疗器械分类目录应当向社会公布。

第五条医疗器械的研制应当遵循安全、有效和节约的原则。

国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。

第六条医疗器械产品应当符合医疗器械强制性国家标准；尚无强制性国家标准的，应当符合医疗器械强制性行业标准。