Seminar on full implementation of medical device registrant system held in Beijing
2021-07-22 14:14:01
On July 20, the seminar on the full 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, the 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 medical device registrant filer system, summarized and exchanged China's experience in the pilot work of the medical device registrant system since 2017, and deeply discussed the working ideas for the full implementation of the medical device registrant filer system in the next step.
The system of medical device registrants and recorders is a basic system that runs through the whole life cycle of medical devices. It is also an important measure for China to thoroughly implement the reform of medical device review and approval system. In december2017, Shanghai launched the pilot of medical device registrant system. In may2018, Guangdong and Tianjin successively launched pilot projects. In 2019, the State Food and drug administration expanded the pilot of the medical device registrant system to 22 provinces (autonomous regions and municipalities). After the implementation of the new regulations on June 1 this year, the medical device registrant filer system will be implemented nationwide as the core system of medical device supervision.
At the meeting, the person in charge of the first registration office of the medical device registration management department of the State Food and Drug Administration introduced the background, progress and results of the pilot work of the medical device registrant system, the key points of the system implementation and the next work ideas. It is reported that in the process of the system pilot, the number of pilot varieties increased significantly, the pilot areas were fully covered, and the types of pilot varieties were rich, covering various types and situations of medical device registration. The pilot work fully reflected the advantages of the registrant system in promoting the optimization and integration of resources, and fully released the innovation and development vitality of the medical device industry.
Professor Yang Yue from the school of pharmacy of Tsinghua University systematically reviewed the pilot implementation process of the medical device registrant system, and pondered and prospected the full implementation of the system. Yang Yue believes that the core function of the registrant filer system is to encourage R & D innovation, optimize resource allocation, strengthen subject responsibility and innovate supervision methods. The pilot work has summed up experience in four aspects: quality management mode, licensing and change procedures, full life cycle management, and cross regional supervision and innovation of entrusted production. The pilot work has achieved remarkable results.
The relevant person in charge of the medical device supervision division of Shanghai food and Drug Administration introduced at the meeting that the Bureau focused on the construction of the pilot system, actively participated in the design of the pilot system, strengthened exchanges and cooperation with the drug regulatory departments of Jiangsu, Zhejiang and Anhui provinces, and jointly studied the feasibility path of the pilot of the cross provincial registrant system. Focus on pilot cases and accumulate practical experience in different combination modes. Pay attention to post Listing Supervision, and promote the smooth implementation of the pilot work of the registrant system through the adoption of a combination of third-party assessment, flight inspection and joint interview.
Medical device enterprises have also accumulated rich experience in the process of system pilot. At the meeting, representatives of Shenzhen Mindray Biomedical Electronics Co., Ltd., BGI gene Co., Ltd. and Beijing xianruida Medical Technology Co., Ltd. shared the implementation path, specific practices and summary thinking of the enterprise pilot. The participants also exchanged and discussed specific issues such as the division of rights and responsibilities between the registrant and the entrusted production enterprise, the signing of contracts and quality agreements, and the determination of production processes.
Relevant principals and comrades of the device registration department of the State Food and Drug Administration and relevant directly affiliated units, relevant principals of the China Institute of drug administration and the medical device industry association, as well as representatives of 10 provincial (District, municipal) drug administrations and 21 medical device enterprises attended the meeting.
The system of medical device registrants and recorders is a basic system that runs through the whole life cycle of medical devices. It is also an important measure for China to thoroughly implement the reform of medical device review and approval system. In december2017, Shanghai launched the pilot of medical device registrant system. In may2018, Guangdong and Tianjin successively launched pilot projects. In 2019, the State Food and drug administration expanded the pilot of the medical device registrant system to 22 provinces (autonomous regions and municipalities). After the implementation of the new regulations on June 1 this year, the medical device registrant filer system will be implemented nationwide as the core system of medical device supervision.
At the meeting, the person in charge of the first registration office of the medical device registration management department of the State Food and Drug Administration introduced the background, progress and results of the pilot work of the medical device registrant system, the key points of the system implementation and the next work ideas. It is reported that in the process of the system pilot, the number of pilot varieties increased significantly, the pilot areas were fully covered, and the types of pilot varieties were rich, covering various types and situations of medical device registration. The pilot work fully reflected the advantages of the registrant system in promoting the optimization and integration of resources, and fully released the innovation and development vitality of the medical device industry.
Professor Yang Yue from the school of pharmacy of Tsinghua University systematically reviewed the pilot implementation process of the medical device registrant system, and pondered and prospected the full implementation of the system. Yang Yue believes that the core function of the registrant filer system is to encourage R & D innovation, optimize resource allocation, strengthen subject responsibility and innovate supervision methods. The pilot work has summed up experience in four aspects: quality management mode, licensing and change procedures, full life cycle management, and cross regional supervision and innovation of entrusted production. The pilot work has achieved remarkable results.
The relevant person in charge of the medical device supervision division of Shanghai food and Drug Administration introduced at the meeting that the Bureau focused on the construction of the pilot system, actively participated in the design of the pilot system, strengthened exchanges and cooperation with the drug regulatory departments of Jiangsu, Zhejiang and Anhui provinces, and jointly studied the feasibility path of the pilot of the cross provincial registrant system. Focus on pilot cases and accumulate practical experience in different combination modes. Pay attention to post Listing Supervision, and promote the smooth implementation of the pilot work of the registrant system through the adoption of a combination of third-party assessment, flight inspection and joint interview.
Medical device enterprises have also accumulated rich experience in the process of system pilot. At the meeting, representatives of Shenzhen Mindray Biomedical Electronics Co., Ltd., BGI gene Co., Ltd. and Beijing xianruida Medical Technology Co., Ltd. shared the implementation path, specific practices and summary thinking of the enterprise pilot. The participants also exchanged and discussed specific issues such as the division of rights and responsibilities between the registrant and the entrusted production enterprise, the signing of contracts and quality agreements, and the determination of production processes.
Relevant principals and comrades of the device registration department of the State Food and Drug Administration and relevant directly affiliated units, relevant principals of the China Institute of drug administration and the medical device industry association, as well as representatives of 10 provincial (District, municipal) drug administrations and 21 medical device enterprises attended the meeting.
