In recent years, the construction of China's medical device guideline system has achieved obvious results: the quality and quantity of guidelines have been significantly improved, and the structure and layout of guidelines have been continuously optimized. By the end of 2023, the number of guidelines formulated and revised in China has reached 613 (see Reference for details), playing a guiding role in registration and technical review in an all-round and multi-angle way. The Center for Medical Device Evaluation (CMDE) will keep insisting on improving the scientific, forward-looking, and leading nature of the guidelines. It will build the foundation of technical documents for reviewing science, promote the effectiveness of medical device regulation, and further assist and guide the high-quality development of the medical device industry.

 

 

Reference:

Medical Device Registration Review Guideline Catalog