The Meeting for Advancing Research on Regulatory System for Administration of Registration of Medical Devices was held by the National Medical Products Administration (“NMPA”) on the morning of November 24 to have a phased summary of the research on the regulatory system for administration of medical devices and further advance the research on the regulatory system for the lifecycles of medical devices.
In order to implement the Implementing Opinions of the General Office of the State Council on Comprehensively Strengthening the Building of Drug Regulation Capability and the newly revised Regulation on the Supervision and Administration of Medical Devices, the NMPA set up 12 medical device regulatory system research groups in reliance on some provincial medical products administrations this March, to further strengthen the research on the regulatory system for the lifecycles of medical devices and continue to improve the scientific and rule-of-law level of regulation of medical devices. Among them, there are five regulatory research groups related to the administration of registration of medical devices, which are the registration administration research group, clinical trial administration research group, classification standard administration research group, UDI research group, and provincial review and approval capability building research group separately led by the medical products administrations of Shanghai, Sichuan, Beijing, Tianjin, and Hebei.
At the meeting, the medical products administrations of Shanghai, Sichuan, Beijing, Tianjin, and Hebei separately reported their research work on the regulatory system for administration of registration of medical devices in the previous phase. Since this March, the registration administration research group has been studying rare medical device administration and medical institution self-developed in vitro diagnostic reagent administration and has proposed preliminary ideas of the administration policy for medical institution self-developed reagents in terms of basic positioning, product scope, access form, clinical use, ex post regulation, etc., fully researched issues such as rare medical device definition, applicable registration paths, and post-marketing regulation, and preliminarily made clear the regulation situations at home and abroad. The clinical trial administration research group has organized various forms of research at home and abroad to understand the status of administration of clinical trial institutions and has further refined the new edition of Good Clinical Practice for Medical Devices, to strongly support the resolution of practical issues in the clinical trial supervision and administration process. The classification standard administration research group has actively advanced the revision of the Class I Medical Device Product Catalog and organized and coordinated other studies on classification standards, to provide effective guidance for revising subsequent documents. The UDI research group has understood the implementation situation of UDI-related regulations and the specific progress and demand of enterprises in implementing UDI and has conducted in-depth research in terms such as improving unique device identifier assignment, expanding application scenarios, realizing accurate tracing, and advancing the integration of medical treatment, medical insurance and medicines supply, to provide useful experience for the comprehensive application of UDI in China. The provincial review and approval capability building research group has conducted a comparative study of domestic and foreign regulatory systems for administration of registration of medical devices, explored in depth the strategy for improving the capabilities of provincial review and approval bodies in China, the review quality management system requirements, the connections between reviews and registration inspections, etc., and formed preliminary suggestions for improving provincial review and approval capability building, to provide a specific direction for the subsequent standardization and unification of administration of registration of medical devices in China.
The phased results in the early research efforts of the five regulatory research groups were fully affirmed at the meeting. It’s pointed out at the meeting that it’s necessary to continue to increase work efforts, keep a close eye on the international frontiers and regulation practice, be problem-oriented and goal-oriented, and strive for more good results as early as possible.
The related heads and staff of the Department of Medical Device Registration, Department of Medical Device Regulation, Center for Medical Device Evaluation, Center for Food and Drug Inspection and Center for Medical Device Standardization Administration under the NMPA attended the meeting on site, and 19 entities including the provincial (municipal) medical products administrations leading and participating in the regulatory research groups and Lecheng Medical Products Administration attended the meeting via video.
Source: National Medical Productions Administration
In order to implement the Implementing Opinions of the General Office of the State Council on Comprehensively Strengthening the Building of Drug Regulation Capability and the newly revised Regulation on the Supervision and Administration of Medical Devices, the NMPA set up 12 medical device regulatory system research groups in reliance on some provincial medical products administrations this March, to further strengthen the research on the regulatory system for the lifecycles of medical devices and continue to improve the scientific and rule-of-law level of regulation of medical devices. Among them, there are five regulatory research groups related to the administration of registration of medical devices, which are the registration administration research group, clinical trial administration research group, classification standard administration research group, UDI research group, and provincial review and approval capability building research group separately led by the medical products administrations of Shanghai, Sichuan, Beijing, Tianjin, and Hebei.
At the meeting, the medical products administrations of Shanghai, Sichuan, Beijing, Tianjin, and Hebei separately reported their research work on the regulatory system for administration of registration of medical devices in the previous phase. Since this March, the registration administration research group has been studying rare medical device administration and medical institution self-developed in vitro diagnostic reagent administration and has proposed preliminary ideas of the administration policy for medical institution self-developed reagents in terms of basic positioning, product scope, access form, clinical use, ex post regulation, etc., fully researched issues such as rare medical device definition, applicable registration paths, and post-marketing regulation, and preliminarily made clear the regulation situations at home and abroad. The clinical trial administration research group has organized various forms of research at home and abroad to understand the status of administration of clinical trial institutions and has further refined the new edition of Good Clinical Practice for Medical Devices, to strongly support the resolution of practical issues in the clinical trial supervision and administration process. The classification standard administration research group has actively advanced the revision of the Class I Medical Device Product Catalog and organized and coordinated other studies on classification standards, to provide effective guidance for revising subsequent documents. The UDI research group has understood the implementation situation of UDI-related regulations and the specific progress and demand of enterprises in implementing UDI and has conducted in-depth research in terms such as improving unique device identifier assignment, expanding application scenarios, realizing accurate tracing, and advancing the integration of medical treatment, medical insurance and medicines supply, to provide useful experience for the comprehensive application of UDI in China. The provincial review and approval capability building research group has conducted a comparative study of domestic and foreign regulatory systems for administration of registration of medical devices, explored in depth the strategy for improving the capabilities of provincial review and approval bodies in China, the review quality management system requirements, the connections between reviews and registration inspections, etc., and formed preliminary suggestions for improving provincial review and approval capability building, to provide a specific direction for the subsequent standardization and unification of administration of registration of medical devices in China.
The phased results in the early research efforts of the five regulatory research groups were fully affirmed at the meeting. It’s pointed out at the meeting that it’s necessary to continue to increase work efforts, keep a close eye on the international frontiers and regulation practice, be problem-oriented and goal-oriented, and strive for more good results as early as possible.
The related heads and staff of the Department of Medical Device Registration, Department of Medical Device Regulation, Center for Medical Device Evaluation, Center for Food and Drug Inspection and Center for Medical Device Standardization Administration under the NMPA attended the meeting on site, and 19 entities including the provincial (municipal) medical products administrations leading and participating in the regulatory research groups and Lecheng Medical Products Administration attended the meeting via video.
Source: National Medical Productions Administration