Catalogue of Guiding Principles for Medical Device Registration Review

  • 2024-01-10
Editor’s note: As a new tool, method and standard for the technical review of medical devices, the guiding principles for medical device registration review (hereinafter referred to as “Guiding Principles”) plays an important role in improving the scientific review capacity and promoting the high-quality development of the industry. The Center for Medical Device Evaluation (CMDE) adheres to the principle of being scientific and constructs the guiding principle system that is adaptable to the development of medical device industry in China. 

In recent years, the construction of guiding principle system for medical devices has been effective in China, with the quality and quantity of guiding principles significantly improved and the structural layout of guiding principles continuously optimized. As of the end of 2023, there have been 613 guiding principles in China formulated and revised (See Annex), which comprehensively play a guiding role in registration application and technical review from multiple perspectives. The CMDE will keep working on providing more scientific, prospective and leading guiding principles, in an effort to lay a solid foundation of scientific technical documents for review, thus promoting the efficiency of medical device regulation, and further guiding and driving the high-quality development of medical device industry.

Annex: Catalogue of Guiding Principles for Medical Device Registration Review (as of the end of 2023) (download)

Source: CMDE