1、1Regulations for the Supervision and Management of Medical DevicesDecree of the State Council of the Peoples 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 promu
2、lgated 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 Peoples Republic of China No. 276 on January 4, 2000, and revised at the 39th executive meeting o
3、f 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 2 All units or individuals engaged in the research an
4、d development, production, distribution, use, supervision and management of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation. Article 3 The food and drug supervision and management department of the State Council shall be responsible for the 2sup
5、ervision 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 peoples governme
6、nt 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 peoples governments above the level of county shall be responsible for the supervision and management relating to medical
7、 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 imple
8、ment 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 con
9、trol is required to ensure their safety and effectiveness Class III Medical Devices are those with higher degree of risk which must be strictly controlled in respect to safety and effectiveness. Evaluation on degree of risk should take into account the anticipated purpose, structural characteristics
10、, 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 3risk ac
11、cording 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 manufac
12、turing 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 if the compulsory national standard is unavailable; comply with the compulsory industria
13、l 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
14、 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
15、 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.4Chapter II Registrati
16、on and Filing of Medical Device ProductsArticle 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
17、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) Product inspection report;(IV) Clinical evaluation materials;(V) Product instruction and label sample;(VI) Qual
18、ity management system documents related to product research (VII) Other 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.Art
19、icle 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 peoples government of the municipality established with districts; in which, product inspection report may be the self-inspec
20、tion 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.5The overseas manufacturing enterprise expor
21、ting Class I medical device to the territory of the Peoples Republic of China shall, through its representative office established within the territory of the Peoples Republic of China or the business entity designated within the territory of the Peoples Republic of China as the agent, submit filing
22、 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
23、 in the filing materials, filing applicant should apply for the filing of change 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 a
24、nd management department of the peoples 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 ma
25、terials 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 Peoples Republic of China, should through its representative office established within the territory of t
26、he Peoples Republic of China or the business entity designated within the territory of the Peoples 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 ma
27、rketing 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 6report issued by medical device inspection agency; clini
28、cal 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 12 The food and drug supervision and management department accepting registration application shall put forward the applic
29、ation materials to technical evaluation institution 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 13 The food and drug
30、 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 Certificat
31、e 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
32、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 tha
33、t 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 handl
34、e 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 7registration department.Article 15 T
35、he valid period of the Medical Device Registration 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
36、 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 regi
37、stration 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 the application for renewing registration within speci
38、fied time;(II) The compulsory standard for medical devices has been revised and the medical device cannot meet new requirements.(III) No formalities about the issues stated in the Medical Device Registration Certificate are completed within specified time for the medical devices available to the rar
39、e 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
40、 class according to classification rules and apply for registration or filing according 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
41、 medical device 8products, 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
42、 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 17 The clinical trial is not required for filing Class I medical device. The clinical trial shall be c
43、onducted 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, mature design and production process; same type of marketed medical device has been in clinical
44、 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) The safety and effectiveness of the medical device can be proved through data analysis and eva
45、luation 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 18 The clinical trial of medical device shall be conducted in the clinical trial institution with
46、 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 peoples government of the province, autonomous region, and municipality directly under the central government where the applican
47、t 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 9competent department of health and family planning at the same
48、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 departme
49、nt 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 19 The 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 dev
