Center for Medical Device Evaluation (CMDE)

The Center for Medical Device Evaluation (CMDE) is a specialized technical review body under the National Medical Products Administration (NMPA) of China. It is responsible for the technical evaluation of registration applications for domestic Class III medical devices and imported Class II and Class III medical devices, as well as the management of clinical trial applications for high-risk devices. CMDE plays a critical role in China's medical device regulatory framework by establishing technical standards, drafting review guidelines, and providing scientific evaluation to ensure the safety and effectiveness of medical devices entering the Chinese market. It operates as a government-affiliated institution rather than a commercial entity.