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§ ASIA-PACIFIC
NMPA
National Medical Products Administration (China)
China
China's NMPA regulates medical devices through CMDE (Center for Medical Device Evaluation) technical reviews. China uses a three-class risk-based system. Foreign manufacturers must appoint a Marketing Authorization Holder (MAH) and complete in-country testing for Class II and III devices. China is the world's second-largest medical device market.
DEVICE CLASSES
Class I, II, III
APPROVAL PATHWAY
NMPA Registration (CMDE review)
KEY REGULATORY FUNCTIONS
- ▸CMDE technical review
- ▸MAH (Marketing Authorization Holder) system
- ▸In-country testing requirements
- ▸Clinical trial oversight
- ▸NMPA registration certificates
OFFICIAL WEBSITE
https://www.nmpa.gov.cn →MedFlux monitors NMPA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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