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The "Regulations on the Supervision and Administration of Medical Devices" are expected to be promulgated this year.
Release time:
2025-03-12 09:42
5GHealthy China Construction in the 5G Era”At a high-level forum, Jiang Deyuan, an inspector from the Medical Device Registration Department of the National Medical Products Administration, revealed that the "Regulations on the Supervision and Administration of Medical Devices" is expected to be promulgated this year.
In recent years, the five key initiatives of the Medical Device Registration Department of the National Medical Products Administration in continuously optimizing its operational mechanisms are:
1. Issuing the "Decision on Adjusting the Approval Procedures for Certain Administrative Matters of Medical Devices", centralizing the previously continued registration and change registration approval processes to the Medical Device Evaluation Center, reducing steps, and improving efficiency.
2. Revising the "Catalog of Medical Devices Exempt from Clinical Trials". So far, a total of1248medical devices are exempt from clinical trials.
3. Continuously promoting the reform of the registrant system. Last year, pilot programs for the registrant system were conducted in Shanghai, Guangdong, and Tianjin, achieving excellent results. A total of8enterprises15products were approved for market launch through this channel. This has now been expanded to21provinces, municipalities, and autonomous regions, and clear requirements have been set for all aspects of the pilot program objectives.
4. Continuously accelerating regulations and infrastructure construction. This includes continuously promoting the revision of the "Regulations on the Supervision and Administration of Medical Devices", which is currently in its final stages and is expected to be promulgated and implemented this year.
5. Fully promoting the unique identification of medical devices. In the future, full traceability will be possible. We are currently cooperating with the National Health Commission to select100medical device manufacturers for pilot programs.
This forum was supported by the National Medical Products Administration Medical Device Technical Review Center and the National Health Commission Health Development Research Center, and jointly organized by the National Health Commission International Exchange and Cooperation Center and the China Academy of Information and Communications Technology, with MedTrend (MedTrend) assisting.
Hopefully, medical device registration, supervision, and continuous approval will be carried out by the health center's regulatory authority.
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