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