ANVISA vs AIFA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of ANVISA (Brazil) vs AIFA (Italy).
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
AIFA
AIFA — Italy Medical Device Regulatory Authority
Italy
AIFA is the national regulatory authority responsible for medical device oversight in Italy. It manages device registration, market surveillance, and adverse event reporting within the Europe regulato…
EU MDR classes
AIFA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both ANVISA and AIFA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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