NMPA (National Medical Products Administration, China)
China's national regulatory authority responsible for approving and overseeing medical devices, pharmaceuticals, and cosmetics. NMPA registration is mandatory for medical devices marketed in mainland China.
The National Medical Products Administration (NMPA), formerly known as CFDA (China Food and Drug Administration), is China's regulatory body for medical devices, drugs, and cosmetics. NMPA classifies medical devices into three classes (I, II, III) and requires registration before any device can be legally sold in mainland China.
NMPA registration process
Foreign manufacturers must work through a Chinese authorized representative (legal agent) and register with NMPA through the applicable provincial or national authority depending on device class. Class II devices are registered at the provincial level; Class III devices require national NMPA approval. The process involves technical review, testing at designated Chinese laboratories, and clinical evaluation — which may require Chinese clinical trials for certain device types.
NMPA in international procurement
For medical device manufacturers targeting the Chinese market, NMPA registration is a prerequisite for participation in Chinese hospital tenders. The registration timeline (12-30 months) must be factored into market entry planning. Procurement teams in China verify NMPA registration certificates as a mandatory compliance check during tender evaluation.