The Seminar on Full Implementation of Medical Device Registrant System was held in Beijing on July 20. As one of the important activities of the National Medical Device Safety Publicity Week 2021, at this meeting, the requirements of the newly-revised Regulations for the Supervision and Administration of Medical Devices (hereinafter referred to as the new Regulations) for medical device registrant and filing applicant system were analyzed and interpreted; besides, the experience in the pilot work of medical device registrant system in China since 2017 was summarized and exchanged; and the working ideas for fully implementing the medical device registrant and filing applicant system were explored in depth.
The medical device registrant and filing applicant system is a basic system that runs through the whole life cycle of medical devices, and is also an important measure for China to deeply implement the reform of medical device review and approval system. In December 2017, Shanghai started the pilot work of medical device registrant system. In May 2018, Guangdong and Tianjin initiated the pilot work successively. In 2019, the National Medical Products Administration (NMPA) expanded the pilot work of the medical device registrant system to 22 provinces (autonomous regions and municipalities). After the new Regulations came into effect on June 1 this year, the medical device registrant and filing applicant system will be implemented nationwide as the core system of medical device supervision.
At the meeting, the director of Medical Device Registration Management Division 1 of the NMPA introduced the background, progress and effectiveness of work, key points of system implementation and the next working ideas of pilot work on medical device registrant system. According to the introduction, during the pilot work, the number of pilot varieties has increased significantly; the pilot areas have a complete coverage; the types of pilot varieties are rich and cover all types and situations of medical device registration. The pilot work fully reflects the advantages of the registrant system in promoting the optimization and integration of resources and fully releases the innovation and development vitality of the medical device industry.
Yang Yue, a Professor from the School of Pharmacy, Tsinghua University, systematically reviewed the implementation process of medical device registrant system and thought about and looked forward to the comprehensive implementation of the system. Yang Yue held that the core functions of the registrant and filing applicant system are to encourage R&D and innovation, optimize resource allocation, strengthen main responsibilities and innovate supervision methods. The experience has been summarized in four aspects of the pilot work, quality management model, licensing and change procedures, full life cycle management, commissioned production cross-regional supervision innovation. Significant pilot results have been achieved.
The director of the Department of Medical Device Supervision, Shanghai Food and Drug Administration, introduced at the meeting that the Administration focuses on the construction of the pilot system, actively participates in the design of pilot system, and strengthens the exchange and cooperation with drug administrations of Jiangsu Province, Zhejiang Province and Anhui Province to jointly study the feasibility path of the pilot of the interprovincial registrant system. Pilot cases are collected to accumulate the practice experience in different combination modes. The post-marketing supervision is stressed to promote the smooth development of trials on the registrant system by taking the supervision measures combining third-party evaluation, unannounced inspection and joint interviews.
Medical device enterprises have also accumulated rick experience in the system pilot process. At this meeting, representatives of Shenzhen Mindray Biological Medical Electronics Co., Ltd., Shenzhen BGI Technology Co., Ltd., and Beijing XRD Medical Technology Co., Ltd. shared their pilot implementation path, specific practices and summary thinking. Representative present at the meeting 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 process.
The responsible persons and comrades of Device Registration Division of the NMPA and relevant directly affiliated units, responsible persons of China Society for Drug Regulation and China Association for Medical Devices Industry, and representatives of the drug administrations of 10 provinces (autonomous regions and municipalities) and 21 medical device enterprises attended the meeting.
The medical device registrant and filing applicant system is a basic system that runs through the whole life cycle of medical devices, and is also an important measure for China to deeply implement the reform of medical device review and approval system. In December 2017, Shanghai started the pilot work of medical device registrant system. In May 2018, Guangdong and Tianjin initiated the pilot work successively. In 2019, the National Medical Products Administration (NMPA) expanded the pilot work of the medical device registrant system to 22 provinces (autonomous regions and municipalities). After the new Regulations came into effect on June 1 this year, the medical device registrant and filing applicant system will be implemented nationwide as the core system of medical device supervision.
At the meeting, the director of Medical Device Registration Management Division 1 of the NMPA introduced the background, progress and effectiveness of work, key points of system implementation and the next working ideas of pilot work on medical device registrant system. According to the introduction, during the pilot work, the number of pilot varieties has increased significantly; the pilot areas have a complete coverage; the types of pilot varieties are rich and cover all types and situations of medical device registration. The pilot work fully reflects the advantages of the registrant system in promoting the optimization and integration of resources and fully releases the innovation and development vitality of the medical device industry.
Yang Yue, a Professor from the School of Pharmacy, Tsinghua University, systematically reviewed the implementation process of medical device registrant system and thought about and looked forward to the comprehensive implementation of the system. Yang Yue held that the core functions of the registrant and filing applicant system are to encourage R&D and innovation, optimize resource allocation, strengthen main responsibilities and innovate supervision methods. The experience has been summarized in four aspects of the pilot work, quality management model, licensing and change procedures, full life cycle management, commissioned production cross-regional supervision innovation. Significant pilot results have been achieved.
The director of the Department of Medical Device Supervision, Shanghai Food and Drug Administration, introduced at the meeting that the Administration focuses on the construction of the pilot system, actively participates in the design of pilot system, and strengthens the exchange and cooperation with drug administrations of Jiangsu Province, Zhejiang Province and Anhui Province to jointly study the feasibility path of the pilot of the interprovincial registrant system. Pilot cases are collected to accumulate the practice experience in different combination modes. The post-marketing supervision is stressed to promote the smooth development of trials on the registrant system by taking the supervision measures combining third-party evaluation, unannounced inspection and joint interviews.
Medical device enterprises have also accumulated rick experience in the system pilot process. At this meeting, representatives of Shenzhen Mindray Biological Medical Electronics Co., Ltd., Shenzhen BGI Technology Co., Ltd., and Beijing XRD Medical Technology Co., Ltd. shared their pilot implementation path, specific practices and summary thinking. Representative present at the meeting 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 process.
The responsible persons and comrades of Device Registration Division of the NMPA and relevant directly affiliated units, responsible persons of China Society for Drug Regulation and China Association for Medical Devices Industry, and representatives of the drug administrations of 10 provinces (autonomous regions and municipalities) and 21 medical device enterprises attended the meeting.
Source: China Pharmaceutical News, health commissions