Seminar on comprehensive implementation of medical device registrant system was held in Beijing
Time:
2021-07-22
Source:
China Medical News, Health Commission
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On July 20, a seminar on the comprehensive implementation of the medical device registrant system was held in Beijing. As one of the important activities of the National Medical Device Safety Publicity Week in 2021, this meeting analyzed and interpreted the requirements of the newly revised "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the new "Regulations") on the registration system of medical device registrants, and summarized exchanges. Based on the pilot work experience of my country's medical device registrant system since 2017, it deeply explored the working ideas of the next step to fully implement the medical device registrant system.
The registration system of medical device registrants is a basic system that runs through the entire life cycle of medical devices. It is also an important measure for my country to thoroughly implement the reform of the medical device review and approval system. In December 2017, Shanghai launched a pilot program for the registrant system of medical devices. In May 2018, Guangdong and Tianjin successively started pilot work. In 2019, the State Food and Drug Administration will expand the pilot system of medical device registrants to 22 provinces (regions and cities). After the implementation of the new "Regulations" on June 1 this year, the medical device registrant registration system will be implemented as a core medical device supervision system across the country.
At the meeting, the person in charge of the Registration Division I of the Medical Device Registration Management Department of the State Drug Administration introduced the background of the pilot work of the medical device registrant system, the progress of the pilot and the results, the key points of the implementation of the system and the ideas for the next step. According to reports, during the system pilot process, the number of pilot varieties has increased significantly, the pilot areas are fully covered, and the pilot varieties are rich in types, covering various types and situations of medical device registration. The pilot work fully reflects the registrant system's promotion of resource optimization and integration. The advantages have fully released the vitality of the innovation and development of the medical device industry.
Professor Yang Yue of the School of Pharmacy of Tsinghua University systematically reviewed the implementation process of the pilot medical device registrant system, and thought about the overall implementation of the system. Yang Yue believes that the core function of the registrant filing system is to encourage R&D innovation, optimize resource allocation, strengthen main responsibility, and innovate regulatory methods. The pilot work has summed up experience in the four aspects of quality management model, licensing and change procedures, full life cycle management, and commissioned production cross-regional supervision and innovation, and the pilot has achieved remarkable results.
The relevant person in charge of the Medical Device Supervision Department of the Shanghai Municipal Drug Administration said at the meeting that the bureau focused on the construction of the pilot system, actively participated in the design of the pilot system, and strengthened exchanges and cooperation with the Jiangsu, Zhejiang and Anhui drug regulatory authorities to conduct joint research. Feasible path for piloting the inter-provincial registrant system. Grasp pilot cases and accumulate practical experience in different combination models. Focus on post-listing supervision, and promote the smooth development of pilot work on the registrant system by adopting supervision measures that combine third-party assessment, unannounced inspections, and joint interviews.
Medical device companies have also accumulated a wealth of experience in the system pilot process. At the meeting, representatives of Shenzhen Mindray Bio-Medical Electronics Co., Ltd., BGI Gene Co., Ltd., and Beijing Xianruida Medical Technology Co., Ltd. shared their pilot implementation paths, specific methods, and summary thoughts. Participants also exchanged views on specific issues such as the division of rights and responsibilities between the registrant and the entrusted manufacturer, the signing of contracts and quality agreements, and the determination of production processes.
Relevant persons in charge and comrades of the Device Registration Department of the State Food and Drug Administration and related directly affiliated units, relevant persons in charge of the China Society for Drug Administration, Medical Device Industry Association, and 10 provincial (regional, municipal) drug regulatory bureaus and 21 medical device companies Delegates attend the meeting.
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