NMPA vs ANVISA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of NMPA (China) vs ANVISA (Brazil).
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…
Class I, II, III
NMPA Registration (CMDE review)
- ▸CMDE technical review
- ▸MAH (Marketing Authorization Holder) system
- ▸In-country testing requirements
- ▸Clinical trial oversight
- ▸NMPA registration certificates
ANVISA
Agência Nacional de Vigilância Sanitária (Brazil)
Brazil
ANVISA regulates medical devices in Brazil using a four-class risk-based system. Brazil is an MDSAP participating country. ANVISA requires a Brazilian Registration Holder (BRH) for foreign manufacture…
Class I, II, III, IV
ANVISA cadastro (Class I-II) / registro (Class III-IV)
- ▸Device registration (cadastro/registro)
- ▸Brazilian Registration Holder requirement
- ▸MDSAP participation
- ▸GMP (INMETRO) certification
- ▸ANVISA Technical Opinion
MedFlux monitors both NMPA and ANVISA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
COMPARE LIVE DATA FREE →