Symposium on Special Rectification of Medical Device Quality and Safety in 2023 (Area) Held in Shanghai

In order to further promote the in-depth development of the special rectification work on the quality and safety of medical devices and effectively improve the level of medical device quality and safety assurance, on May 16, the State Food and Drug Administration held a symposium on the special rectification work (area) of medical device quality and safety in 2023 in Shanghai.

The participating provincial bureaus reported the progress of the special rectification of medical device quality and safety in 2023, and the State Administration's Verification Center and Information Center respectively introduced the unannounced inspection of medical devices and the information construction of post-marketing supervision. The participating units exchanged views on the two themes of the selected medical devices and the production supervision entrusted by the registrant.

meeting positively evaluated the phased results of the special rectification of medical device quality and safety, and put forward specific requirements for the next step: first, overall development and safety. It is necessary to bear in mind that the country is the largest, conscientiously perform its regulatory duties, continuously strengthen the regulatory system and regulatory capacity building, earnestly implement the "three responsibilities" of enterprises, regulatory departments and local governments, and promote the high-quality development of the industry through strong supervision. Second, we should carry out in-depth risk investigation and rectification. Adhere to the problem-oriented, focus on key products and key links, strictly prevent and control risks. We should continue to strengthen the quality supervision of key products and key links such as epidemic prevention and control medical devices, sterile and implantable medical devices, national centralized procurement of selected medical devices and third-party service platforms for online sales, so as to ensure that the frequency and intensity of supervision are not reduced, and that all kinds of hidden risks are sorted out and dealt with in a timely and effective manner. Third, we should continue to deepen risk consultation. To focus on risk, focus on products, focus on enterprises, focus on disposal, regularly organize and carry out medical device quality and safety risk consultation, the implementation of risk hidden danger "list system" "sales number system", the formation of risk disposal "closed loop". The higher-level regulatory department shall supervise and inspect the risk consultation of the lower-level regulatory department. Fourth, we must continue to strengthen sampling and monitoring. To do a good job in accordance with the requirements of the national medical device quality sampling work plan. Promote the construction of medical device adverse event system, and effectively improve the ability of adverse event monitoring, evaluation and disposal. Fifth, we must crack down on violations of laws and regulations. It is necessary to insist that cases must be investigated and violations must be investigated, implement the requirements of punishing people for illegal acts, promptly transfer clues of suspected crimes, strengthen departmental coordination, and form a joint force for rectification. Sixth, we should continue to strengthen the publicity of laws and regulations. We should continue to publicize laws and regulations and intensify training. In conjunction with the Medical Device Safety Publicity Week, actively carry out law popularization, unblock social supervision channels, enhance public awareness of safe use of equipment, and effectively ensure the safety of the people's use of equipment.

meeting emphasized that drug regulatory authorities at all levels must deeply understand the importance of strengthening the supervision of selected medical devices in centralized procurement and the supervision of production entrusted by registrants, comprehensively implement policies and multiple measures, effectively strengthen the supervision of registrants, and further strengthen the legal representatives of enterprises, The training of "key minorities" such as representatives, manager representatives, and quality leaders will fully implement the registrant's full life cycle quality management responsibilities. Vigorously strengthen supervision and inspection, strengthen information exchange, take risk as the guidance, strictly supervise quality, prevent hidden risks, and effectively ensure the safety of people's use of equipment.

, responsible comrades of relevant departments and inspection centers of device supervision, relevant responsible comrades and staff of the device supervision department, verification center, evaluation center and information center of the State Drug Administration attended the meeting.