In order to further strengthen the supervision of the entrusted production of medical device registrants, and effectively strengthen the implementation of the main responsibility for product quality and safety of medical device registrants and the territorial supervision responsibilities, on June 17, 2022, the State Food and Drug Administration organized a seminar on the commissioned production of medical device registrants. The meeting will be held via video conference.
At the meeting, 5 companies including Beijing Aikang Yicheng Medical Equipment Co., Ltd., Shanghai MicroPort Medical Equipment (Group) Co., Ltd., United Imaging (Changzhou) Medical Technology Co., Ltd., Qingdao DaVinci Technology Co., Ltd. and Aotai Medical System Co., Ltd. Enterprises exchanged experiences on entrusted production and the operation of enterprise quality management system; the Beijing, Shanghai, Hunan and Guangdong Food and Drug Administration combined to implement territorial supervision responsibilities, strengthen cross-regional collaborative supervision, and improve the risk consultation mechanism. The progress, achievements and suggestions for further promoting the registrant system were exchanged and made; the responsible comrades of the relevant departments and bureaus of the State Food and Drug Administration listened to the progress of the work, as well as 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 the "Opinions on Strengthening the Collaborative Supervision of Cross-regional Entrusted Production of Medical Devices" and the "Notice on Issuing the Guidelines for the Compilation of Quality Agreements for the Entrusted Production of Medical Devices" Documents; vigorously promote the construction of supervision informatization, build a national bureau data sharing platform through the effective collection of data from provincial bureaus and directly affiliated units, and realize the co-construction, sharing and sharing of relevant medical device product data and information; Deploy in-depth investigation of potential medical device quality and safety risks In the rectification work, the supervision and inspection of the registrant and the entrusted production enterprises and the investigation and punishment of illegal acts have been strengthened, and various work has achieved certain results. The meeting emphasized that drug regulatory authorities at all levels should be prepared for danger, conduct in-depth analysis and research on various problems encountered in the implementation of the registrant system, find out the nature of the problem, find the crux of the problem, strengthen responsibility, strengthen supervision linkage, and continuously improve long-term supervision. Mechanism to effectively guarantee the quality and safety of medical device products.
The meeting put forward four requirements for the next step: First, implement responsibilities and ensure quality and safety. The registrant is required to effectively implement the main responsibility for product quality and safety. The entrusted production enterprise should effectively implement the production management responsibility, improve the quality management system and maintain effective operation. The second is to be strict and practical, and strengthen supervision and inspection. It is required to make good use of various inspection methods such as supervision and inspection, joint inspection and entrusted inspection, increase supervision and inspection, and strictly investigate and deal with violations of laws and regulations in accordance with the "four strictest" requirements. The third is to strengthen linkage and promote regional cooperation. It is required that for cross-regional entrusted production, the provincial bureaus should strengthen cooperation and close cooperation in accordance with the division of responsibilities, and establish and improve a cross-regional and cross-departmental linkage mechanism. The fourth is social co-governance to promote the healthy development of the industry. It is required to give full play to the regulatory role of the regulatory department, the role of social supervision, and the role of industry associations to jointly promote the high-quality development of the medical device industry.
Department of Device Registration, Department of Device Supervision, State Food and Drug Administration, relevant responsible comrades of China National Inspection Institute, Inspection Center, Evaluation Center, Acceptance and Reporting Center, and Information Center, Beijing, Liaoning, Shanghai, Jiangsu, Zhejiang, Jiangxi, Shandong, Hunan, Guangdong The comrades in charge of drug administrations in 11 provinces (municipalities), including Sichuan and Shaanxi, and 5 medical device registrants and principals of entrusted production enterprises participated in the symposium online.