ANVISA vs INVIMA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of ANVISA (Brazil) vs INVIMA (Colombia).
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
INVIMA
INVIMA — Colombia Medical Device Regulatory Authority
Colombia
INVIMA is the national regulatory authority responsible for medical device oversight in Colombia. It manages device registration, market surveillance, and adverse event reporting within the Latin Amer…
Class I, IIa, IIb, III
INVIMA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both ANVISA and INVIMA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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