医疗器械监督管理系统条例第650令英文翻译版本.docx

1、医疗器械监督管理系统条例第650令英文翻译版本Regulations 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,

2、 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 Peoples Republic of China No. 276 on January 4, 2000, and revised at the 3

3、9th 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 2 All units or individuals eng

4、aged in the research and 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 r

5、esponsible 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

6、local peoples 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 peoples governments above the level of county shall be responsible for the supervision and manageme

7、nt 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

8、 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

9、 for which further control 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, stru

10、ctural 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 chan

11、ge 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 m

12、edical 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, eff

13、ectiveness 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 ind

14、ustry.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, adjust

15、ed 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. F

16、or 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-dis

17、cipline, 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 Device ProductsArticle 8 Product filing management shall be implemented on C

18、lass 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

19、 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) Quality management system documents related to product research & manufacture and production;(VII) Other

20、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 app

21、licant 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-inspection report of the filing applicant; clinical evaluation materials exclu

22、de 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 Peoples Republic of C

23、hina 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 materials and the evidential documents approved by the competent departm

24、ent 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 of

25、 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 and management department of the peoples government of the province, auton

26、omous 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

27、 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 the Peoples Republic of China or the business entity designated within the

28、 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 marketing of the medical device to the food and drug supervision and manage

29、ment 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

30、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 application materials to technical evaluation institution within 3 working days

31、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 supervision and management department accepting registration application

32、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