(1) Industry policy and management system
The competent authority of China's medical device industry is the Medical Device Registration Management Department, the Medical Device Supervision Department and the Supervision Bureau under the State Food and Drug Administration. The state adopts a combination of macro-control and industry self-discipline in the medical device industry. .
1. Industry authorities
The Department of Medical Device Registration Management has the following main responsibilities: (1) organizing and formulating medical device registration management system and supervising implementation; (2) organizing and formulating medical device standards, classification rules, naming rules and coding rules; (3) strictly complying with laws and regulations The prescribed conditions and procedures apply for the registration of the third category of imported medical device products, the approval of clinical trials of high-risk medical devices, and assume corresponding responsibilities, optimize the registration management process, and organize the implementation of classified management; (4) organize the qualification of medical device clinical testing institutions It is recognized that it supervises the implementation of medical device clinical trial quality management norms, supervises and inspects clinical trial activities; (5) directs supervision and acceptance of medical device registration work related to acceptance, review, testing, inspection, filing, etc.; (6) development of medical device registration license Work specifications and technical support capacity building requirements and supervision implementation. Supervise and urge the lower-level administrative organs to strictly implement the registration of Class I and II medical device products in accordance with the law, perform supervision and management responsibilities, and timely discover and correct illegal and improper behaviors.
The Department of Medical Device Supervision has the following main responsibilities: (1) Mastering the analysis of the safety situation of medical devices, existing problems, and proposing suggestions for improving the system and improving work; (2) Organizing and formulating management systems for the production, operation and use of medical devices and supervising the implementation Organize and formulate quality management regulations for the production, operation and use of medical devices and supervise their implementation. To formulate and supervise the implementation of the medical device Internet sales supervision and management system; (3) Organize the supervision and inspection of medical device production and operation enterprises and use links, organize the monitoring and re-evaluation of medical device adverse events, supervise sampling and safety risk assessment, and discover (4) to formulate management systems for the inspection of overseas medical device manufacturing enterprises and supervise their implementation, organize and carry out matters related to the supervision and management of export of medical device products; (5) formulate a system for recalling and disposing medical device products, and guide the supervision of local Relevant work; (6) Formulate requirements for medical device supervision and management work standards and technical support capacity building, and urge subordinate administrative organs to strictly implement administrative licensing, perform supervision and management responsibilities according to law, and timely discover and correct illegal and improper behaviors.
The main inspector of the Inspectorate is to formulate and review the implementation of the drug, medical device and health food advertising review system.
The National Development and Reform Commission is responsible for organizing and implementing the industrial policy of the pharmaceutical industry, researching and formulating the development plan for the medical device industry, guiding the adjustment of the industry structure and implementing industry management.
China Medical Device Industry Association is an internal management organization of the industry. It is mainly responsible for conducting research and development of industry development issues, organizing and supervising the implementation of industry policies, and formulating industry development plans. The Chinese government implements strict supervision of the medical device industry, and the food and drug administrations at all levels are the main regulatory authorities for the production and sale of medical devices.
2. Industry supervision system
China's medical device industry currently implements classified supervision and management. On the one hand, it supervises products, on the other hand, it supervises manufacturing companies Supervised products are designed to verify the safety and effectiveness of the product. The supervision company aims to ensure that the product quality is stable, safe and effective, and is reflected in the audit of the quality management system of the manufacturing enterprise and regular review. The quality management system standard for reviewing medical devices in China is YY/T0287-2003, which is equivalent to the international medical device industry standard ISO13485.
The classification management of medical device products implemented by the state is as follows:
Class I is a medical device that has a low level of risk and is routinely managed to ensure its safety and effectiveness.
Class II is a medical device that has a moderate risk and requires strict control and management to ensure its safety and effectiveness.
Class III is a medical device that is at high risk and requires special measures to strictly control management to ensure its safety and effectiveness.
(1) The state implements a licensing system for medical device management
In the case of Class I medical device business activities, there shall be business premises and storage conditions appropriate to the scale of operation and business scope, as well as quality management systems and quality management institutions or personnel appropriate to the medical devices being operated.
For the operation of Class II medical devices, the operating enterprise shall file with the food and drug supervision and administration department of the municipal people's government where the locality is located and submit the certification materials that meet the conditions for operating Class I medical devices. For the operation of Class III medical devices, the operating enterprise shall apply to the food and drug supervision and administration department of the municipal people's government in the locality to apply for a business license and submit the certification materials that meet the conditions for operating Class I medical devices.
(2) Medical device product registration and filing
The first type of medical devices are subject to product filing management, and the second and third types of medical devices are subject to product registration management. In addition, when medical device products enter the international market, it is necessary to apply the laws and regulations governing medical device management in the importing country.
3. Major industry policies and regulations
(1) Major laws and regulations affecting the industry in recent years:
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