RAPath Brazil
ANVISA Medical Device Regulatory Reference
RAPath BR is a plain English reference for medical device regulation in Brazil under ANVISA (Agência Nacional de Vigilância Sanitária). It is designed for regulatory affairs professionals, manufacturers, importers, distributors, and consultants who need to find and understand Brazilian requirements quickly — especially those already familiar with the EU MDR, FDA, TGA, or Health Canada frameworks.
This site does not replace official ANVISA sources. Every page links back to the authoritative legislative text or official ANVISA guidance. Think of RAPath BR as a structured, searchable reference that helps you locate and understand ANVISA requirements — then verify the specific details against the official source before making regulatory decisions.
Regulatory Pathway Map
Click a phase to expand — each card links to the relevant section of this guide.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for ANVISA requirements you navigate daily, with every claim linked to its legislative source.
Manufacturers (domestic and overseas) — understand what ANVISA requires of you, and how it relates to frameworks you may already know (EU MDR, FDA 21 CFR, TGA, Health Canada).
Importers and distributors — understand your AFE (Autorização de Funcionamento de Empresa), Responsável Técnico obligations, and NOTIVISA reporting duties.
Anyone new to Brazilian medical device regulation — start with Start Here for a guided introduction to the ANVISA framework.
How to use this site
The site is structured around the regulatory lifecycle of a medical device in Brazil:
| Section | What it covers |
|---|---|
| Start Here | Definitions, ANVISA framework overview, who needs to comply, device lifecycle |
| Pre-Market | Classification (Class I–IV), Notificação/Cadastro/Registro, clinical evidence, special device types |
| Post-Market | Tecnovigilância, NOTIVISA, recalls, PMS, labelling, establishment authorisation |
| GMP & Quality (CBPF) | RDC 752/2022, CBPF certificate, ANVISA inspections, CAPA, ISO 13485 alignment |
| Importers, Distributors & Traceability | AFE, Responsável Técnico, SISCOMEX, NCM codes, FSC, UDI/rastreamento |
| Legislation & Regulations | Key RDCs, Leis, MERCOSUL resolutions, ABNT standards |
| Guidance Documents | ANVISA Notas Técnicas, Q&As, Peticionamento guides, forms |
| Special Access & Programmes | Uso Compassivo, Acesso Ampliado, PDP, BNDES/FINEP |
| International & Comparison | IMDRF, ANVISA vs FDA/TGA/CE/HC, CFG, multi-market strategy |
| Enforcement & Compliance | ANVISA inspections, VISA overlap, fines, interdição, registration cancellation |
| Digital Health & SaMD | SaMD, AI/ML, mobile apps, cybersecurity, LGPD |
| What's New | Recent RDC changes, draft regulations, open audiências públicas |
What this site is not
- Not legal or regulatory advice. Always consult qualified regulatory counsel before making submission or compliance decisions.
- Not affiliated with ANVISA. This site is not produced by or on behalf of ANVISA or the Brazilian Government.
- Not a substitute for official sources. Every page links to the relevant ANVISA guidance, RDC, or legislation — always verify there.
Content currency
This site was last reviewed in May 2026. ANVISA regulations change frequently — particularly following the landmark RDC 751/2022 framework that replaced the older RDC 185/2001. Check What's New for recent updates.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official ANVISA sources before making regulatory decisions.