ANVISA
Agência Nacional de Vigilância Sanitária (Brazil)
Brazil
Last reviewed 2026-06-21
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 manufacturers and has specific Portuguese-language labeling requirements.
DEVICE CLASSES
Class I, II, III, IV
APPROVAL PATHWAY
ANVISA cadastro (Class I-II) / registro (Class III-IV)
KEY REGULATORY FUNCTIONS
- ▸Device registration (cadastro/registro)
- ▸Brazilian Registration Holder requirement
- ▸MDSAP participation
- ▸GMP (INMETRO) certification
- ▸ANVISA Technical Opinion
OFFICIAL WEBSITE
https://www.gov.br/anvisa →§ FAQ
What is ANVISA medical device registration in Brazil?
ANVISA (Agência Nacional de Vigilância Sanitária) regulates medical devices in Brazil using two registration types: cadastro (simplified notification for Class I-II) and registro (full registration for Class III-IV). Foreign manufacturers must appoint a Brazilian Registration Holder (BRH). Brazil is an MDSAP participating country, allowing single-audit compliance.
MedFlux monitors ANVISA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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