Regulation on the Supervision and Administration of Medical Devices (2017 Revision)

Regulation on the Supervision and Administration of Medical Devices (2017 Revision) Regulation on the Supervision and Administration of Medical Devices (Promulgated by the Order No. 276 of the State Council of the People's Republic of China on January 4, 2000; revised and adopted at the 39th executive meeting of the State Council on February 12, 2014; and revised in accordance with the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices on May 4, 2017) Chapter I General Provisions Article 1 This Regulation is formulated for the purposes of ensuring the safety and effectiveness of medical devices and guaranteeing human health and life safety. Article 2 Whoever engages in the research and development, production, operation, use as well as supervision and administration of medical devices within the territory of the People's Republic of China shall abide by this Regulation. Article 3 The food and drug supervision and administration department of the State Council shall be responsible for the supervision and administration of the medical devices nationwide. The relevant departments of the State Council shall be responsible for the supervision and administration with respect to medical devices within their respective functions. The food and drug supervision and administration departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative regions. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration with respect to medical devices within their respective functions. The food and drug supervision and administration department of the State Council shall cooperate with the relevant departments of the State Council to implement the national plans and policies on the medical device industry. Article 4 The state shall conduct the classification administration of medical devices according to their risk levels. Medical devices of Class I means the medical devices with low risks, whose safety and effectiveness can be ensured through routine administration. Medical devices of Class II means the medical devices with moderate risks, which shall be strictly controlled and administered to ensure their safety and effectiveness. Medical devices of Class III means the medical devices with relatively high risks, which shall be strictly controlled and administered through special measures to ensure their safety and effectiveness. The evaluation of the risk levels of medical devices shall take consideration of the expected objectives, structural features, use methods and other factors of medical devices. The food and drug supervision and administration department of the State Council shall be responsible for formulating the classification rules for and the classified catalogues of medical devices, and, according to the information on the production, operation and use of medical devices, timely analyzing and evaluating the risk changes of medical devices, and adjusting the classified catalogues; and shall formulate and adjust the classified catalogues, fully listen to the opinions of the production and operation enterprises, use entities and industry organizations of medical devices, and, conduct the classified practices by reference to those for international medical devices. The classified catalogues of medical devices shall be announced to the general public. Article 5 The research and development of medical devices shall follow the principles of safety, effectiveness and economy. The state shall encourage the research and innovation of medical devices, and maximize the role of the market mechanism to promote the popularization and application of new technologies in medical devices, and drive the development of the medical device industry. Article 6 The medical device products shall satisfy the national compulsory standards for medical devices, and, if no such standard is available, meet the compulsory industry standards for medical devices. The catalogue of single-use medical devices shall be formulated, adjusted and published by the food and drug supervision and administration department of the State Council jointly with the administrative department of health and family planning of the State Council. The medical devices whose safety and effectiveness can be ensured when being reused shall not be listed in the catalogue of single-use medical devices. The medical devices whose safety and effectiveness can be ensured when being reused due to the improvements in designs, production technologies, disinfection and sterilization technologies, etc. shall be removed from the catalogue of single-use medical devices. Article 7 The medical device industry organizations shall strengthen the industry self-regulation, promote the construction of credit system, urge enterprises to conduct production and operation activities in accordance with the law, and guide enterprises to act in good faith. Chapter II Registration and Recordation of Medical Device Products Article 8 The medical devices of Class I shall be subject to the product recordation administration, and the medical devices of Class II and Class III shall be subject to the product registration administration. Article 9 The following materials shall be submitted for the recordation of the medical device products of Class I and the application for registration of the medical device products of Class II and Class III: (1) Product risk analysis materials. (2) Product technical requirements. (3) Product inspection reports. (4) Clinical evaluation materials. (5) Sample manuscripts of product instructions and labels. (6) Quality management system documents with respect to product research, development and production. (7) Other materials required to prove the safety and effectiveness of the products. Medical device registration applicants and the parties undergoing recordation of medical devices shall be responsible for the authenticity of the materials submitted by them. Article 10 For the recordation of the medical device products of Class I, the parties undergoing recordation of medical devices shall submit the recordation materials to the food and drug supervision and administration departments of the local people's government at the districted city level. The product inspection reports thereof may be the self-inspection reports of the parties undergoing recordation of medical devices, and the clinical evaluation materials thereof exclude clinical trial reports, and may be the materials capable of proving the safety and effectiveness of the medical devices through literatures or the data obtained from the clinical application of similar products. Where any overseas production enterprises export the medical devices of Class I to the territory of China, the representative offices established by them within the territory of China or the incorporated enterprises within the territory of China designed by them as agents shall submit to the food and drug supervision and administration department of the State Council the recordation materials and the documents certifying the approval of the marketing of such medical devices by the competent departments in the countries (regions) where the parties undergoing recordation of medical devices are located. In case of any change of the matters as specified in the recordation materials, the recordation shall be modified at the original recordation departments. Article 11 To apply for the registration of the medical device products of Class II, registration applicants shall submit the registration application materials to the food and drug supervision and administration departments of the people's governments of the provinces, autonomous regions or municipality directly under the Central Government where such applicants are located. To apply for the registration of the medical device products of Class III, registration applicants shall submit the registration application materials to the food and drug supervision and administration department of the State Council. Where any overseas production enterprises export the medical devices of Class II and III to the territory of China, the representative offices established by them within the territory of China or the incorporated enterprises within the territory of China designed by them as agents shall submit to the food and drug supervision and administration department of the State Council the registration application materials and the documents certifying the approval of the marketing of such medical devices by the competent departments in the countries (regions) where the registration applicants are located The product inspection reports amid the application materials for the registration of the medical device products of Class II and Class III shall be the inspection reports issued by the medical device inspection institutions. Clinical evaluation materials shall include clinical trial reports, but exclude the reports on the medical devices exempt from clinical trials in accordance with the provisions of Article 17 of this Regulation. Article 12 The food and drug supervision and administration departments accepting registration applications shall, within three working days from the dates of acceptance of applications, transfer the registration application materials to technical review institutions. Technical review institutions shall, after completing the technical review, submit the review opinions to food and drug supervision and administration departments. Article 13 The food and drug supervision and administration departments accepting registration applications shall make decisions within 20 working days from the dates when the review opinions are received. The medical devices which meet the safety and effectiveness requirements shall be approved to be registered, and the medical device registration certificates shall be issued thereto, and for those failing to meet the requirements, the registration applications thereof shall be denied and the reasons therefor shall be given in writing. Where the food and drug supervision and administration department of the State Council deems that it is necessary to verify the quality management system when organizing a technical review on any imported medical devices, it shall authorize a technical institution for quality management system inspection to conduct the verification of the quality management system. Article 14 In case of any substantial change of the designs, raw materials, production technologies, scopes of application and application methods, etc., of the registered medical device products of Class II or Class III, which may affect the safety and effectiveness of such medical devices, the registrants shall apply to the original registration departments for undergoing the formalities for registration modification. In case of any non-substantial change thereof, which do not affect the safety and effectiveness of such medical devices, the information on the change shall be reported to the original registration departments for recordation. Article 15 A medical device registration certificate shall be valid for five years. If the registration of a medical device registration certificate needs to be renewed upon the expiration of its validity period, an application for registration renewal shall be filed with the original registration department six months before the validity period expires. Except for the circumstances as prescribed in Paragraph 3 of this Article, the food and drug supervision and administration department receiving the registration renewal application shall make a decision on whether to approve the renewal thereof prior to the expiration of the medical device registration certificate. The failure to make such a decision within a prescribed time limit shall be deemed as the approval of the renewal. A registration shall not be renewed under any of the following circumstances: (1) The registrant fails to file a registration renewal application within a prescribed time limit. (2) The compulsory standards for medical devices have been revised, and the medical devices subject to the application for registration renewal fail to meet the new requirements. (3) The matters as specified in the medical device registration certificate fails to be completed within a prescribed time limit with respect to the medical devices used for treating rare diseases or urgently needed to respond to public health emergencies. Article 16 For the newly researched and developed medical devices which have not been listed in the classified categories, applicants may directly apply for the product registration in accordance with the provisions of this Regulation on the registration of the medical device products of Class III, or may, according to the classification rules, determine the product categories, and apply for the product registration or recordation in accordance with the provisions of this Regulation after applying for the category confirmation to the food and drug supervision and administration department of the State Council. For any direct applications for the registration of the medical device products of Class III, the food and drug supervision and administration department of the State Council shall determine the categories according to the risk levels, and timely incorporate the medical devices approved to be registered into the classified catalogues. Where any application categories have been confirmed, the food and drug supervision and administration department of the State Council shall, within 20 working days from the dates of acceptance of applications, determine the categories of such medical devices and inform the applicants of the determination results. Article 17 Clinical trials are not required for the recordation of the medical devices of Class I, but necessary for the application for the registration of the medical devices of Class II and Class III. However, medical devices may be exempt from clinical trials under any of the following circumstances: (1) The same categories of the marketed medical devices with clear and definite working mechanisms, finalized designs and mature production technologies have been put into clinical application for years, with no record of severely adverse event and with their general purposes unchanged. (2) The safety and effectiveness of such medical devices can be proved through non-clinical evaluation. (3) The safety and effectiveness of such medical devices can be proved through the analysis and evaluation of the data obtained from the clinical trials or clinical application of the same categories of medical devices. The catalogue of the medical devices exempt from clinical trials shall be formulated, adjusted and published by the food and drug supervision and administration department of the State Council. Article 18 The clinical trials of medical devices shall be conducted in the clinical trial institutions that meet the corresponding conditions in accordance with the requirements of the quality management norms for the clinical trials of medical devices , and be reported for recordation to the food and drug administration departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government where the clinical trial presenters are located. The food and drug administration departments accepting the clinical trial recordation shall notify the recordation information to the food and drug administration departments and administrative departments of health and family planning at the same levels at the places where the clinical trial institutions are located. Medical device clinical trial institutions shall be subject to recordation administration. The conditions that medical device clinical trial institutions shall satisfy and recordation administration measures and the clinical trial quality management norms shall be developed and published by the food and drug administration department of the State Council in conjunction with the administrative department of health and family planning of the State Council. Article 19 The medical devices of Class III which may pose relatively high risks to human bodies according to the clinical trials thereof shall be approved by the food and drug supervision and administration department of the State Council. The catalogue of the medical devices of Class III which may pose relatively high risks to human bodies according to the clinical trials thereof shall be formulated, adjusted and published by the food and drug supervision and administration department of the State Council. The food and drug supervision and administration department of the State Council shall, when approving clinical trials, conduct a comprehensive analysis on the devices, professionals and other conditions of the institutions planning to undertake the medical device clinical trials, the risk levels of such medical devices, the implementation plans for the clinical trials, and clinical benefit and risk comparison and analysis reports, etc.. Where any clinical trial is approved, a notification shall be given to the clinical trial presenter and the food and drug supervision and administration department and the administrative department of health and family planning of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial institution is located. Chapter III Production of Medical Devices Article 20 An enterprise engaging in the production of medical devices shall meet the following conditions: (1) Having the production site, environmental conditions, production equipment and professional technicians adaptive to the medical devices produced by it; (2) Having the institution or full-time inspection personnel and the inspection equipment for the quality inspection of the medical devices produced by it. (3) Having the management system able to ensure the quality of medical devices. (4) Having the after-sales service abilities adaptive to the medical devices produced by it. (5) Meeting the requirements as prescribed in the production research and development and production process documents. Article 21 The enterprises engaging in the production of the medical devices of Class I shall report themselves to the drug supervision and administration departments of the local people's governments at the districted city level for recordation and submit the materials certifying their compliance with the conditions as prescribed in Article 20 of this Regulation. Article 22 The enterprises engaging in the production of the medical devices of Class II and Class III shall apply for production licenses to the food and drug supervision and administration departments of the local people's governments of the provinces, autonomous regions or municipalities directly under the Central Government, and submit the materials certifying their compliance with the conditions as prescribed in Article 20 of this Regulation and the registration certificates of the medical devices produced by them. The food and drug supervision and administration departments accepting production licenses shall review the application materials within 30 working days from the dates of acceptance of applications, and conduct verification in accordance with the requirements of the quality management norms for the production of medical devices. For those meeting the conditions as prescribed, permission shall be granted, and the medical device production licenses shall be issued thereto, and for those failing to meet the conditions, no permission shall be granted, and the reasons therefor shall be given in writing. A medical device production license shall be valid for five years. If a medical device production license needs to be renewed upon the expiration of its validity period, the renewal formalities shall be handled in accordance with the relevant legal provisions on administrative licensing. Article 23 The quality management norms for the production of medical devices shall explicitly specify the design and development of medical devices, production equipment conditions, raw material purchase, production process control, institutional setup and staffing of the enterprises and other matters which may affect the safety and effectiveness of medical devices. Article 24 The medical device production enterprises shall, in accordance with the requirements of the quality management norms for the production of medical devices production, establish and improve the quality management systems adaptive to the medical devices produced by them and ensure the effective operation of such medical devices; and shall organize production in strict accordance with the technical requirements for the products subject to registration or recordation to ensure the medical devices leaving factory meet the compulsory standards and the technical requirements for the products subject to registration or recordation. Medical device production enterprises shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit the self-inspection reports to the food and drug supervi......