In order to further strengthen the supervision of the production entrusted by the medical device registrant, and effectively strengthen the implementation of the main responsibility for product quality and safety of the medical device registrant and the territorial supervision responsibility, on June 17, 2022, the State Food and Drug Administration organized a symposium on the production entrusted by the medical device registrant. The meeting was held in the form of video conference.

At the meeting, 5 companies including Beijing Aikang Yicheng Medical Equipment Co., Ltd., Shanghai Minimally Invasive Medical Equipment (Group) Co., Ltd., United Film (Changzhou) Medical Technology Co., Ltd., Qingdao Da Vinci Technology Co., Ltd. and Aotai Medical System Co., Ltd. The company exchanged experiences around commissioned production and the operation of the enterprise quality management system; the Food and Drug Administration of Beijing, Shanghai, Hunan Province, and Guangdong Province combined with the implementation of territorial supervision responsibilities, strengthening cross-regional coordinated supervision, improving the risk consultation mechanism, etc., achieved results, and further promoted the registrant system. The responsible comrades of the relevant departments and bureaus of the State Food and Drug Administration listened to the work development, opinions and suggestions, and responded to relevant issues on the spot.

The meeting pointed out that on the first anniversary of the implementation of the newly revised "Regulations on the Supervision and Administration of Medical Devices", the medical device registrant system has been fully implemented nationwide. The State Food and Drug Administration has continuously improved the construction of the medical device registrant system, and successively issued a series of supporting documents such as "Opinions on Strengthening the Coordinated Supervision of Cross-regional Commissioned Production of Medical Devices" and "Notice on Issuing Guidelines for the Preparation of Quality Agreements for Commissioned Production of Medical Devices"; Vigorously promote the construction of supervision informatization, and build a data sharing platform for national bureaus through the effective collection of data from various provincial bureaus and directly affiliated units, realize the co-construction, sharing and sharing of relevant medical device product data information; deploy in-depth investigation and rectification of medical device quality and safety risks, strengthen the supervision and inspection of registrants and entrusted production enterprises, and investigate and deal with illegal acts, and various tasks have achieved certain results. The meeting stressed that drug regulatory departments at all levels should be prepared for danger in times of peace, deeply analyze and study various problems encountered in the implementation of the registrant system, find out the nature of the problems, find out the crux of the problems, strengthen responsibility, strengthen supervision linkage, constantly improve the long-term supervision mechanism, and effectively ensure the quality and safety of medical device products.