NMPA Overview
NMPA – National Medical Products Administration
China’s top regulatory authority for medical devices, equivalent to the US FDA.
Visit NMPA Website → https://english.nmpa.gov.cn/
Responsibility:
CMDE– Center for Medical Device Evaluation
Responsibility:
The CMDE is responsible for the technical review of domestic Class III and all imported medical devices.
It also oversees the filing of imported Class I devices and the evaluation of registration dossiers for imported Class II and III products on behalf of the NMPA.
Visit CMDE Website:https://www.cmde.org.cn/index.html(partial english)