Regulatory Framework Overview
The three-tier system
Brazil's health surveillance system operates on three tiers:
| Tier | Body | Role |
|---|---|---|
| Federal | ANVISA | Sets national policy, issues RDCs, approves/registers products, grants AFE |
| State | VISA estadual | State-level inspection, licensing, and enforcement |
| Municipal | VISA municipal | Local inspections, operating licences (Licença de Funcionamento) |
Key legislation
| Legislation | Key provision |
|---|---|
| Lei 6.360/1976 | Foundational health surveillance law |
| Lei 9.782/1999 | Creates ANVISA and defines its mandate |
| RDC 751/2022 | Core regulation for medical device registration |
| RDC 752/2022 | Good Manufacturing Practices (GMP/CBPF) |
| RDC 753/2022 | Adverse event reporting and recalls |
| RDC 754/2022 | Labelling requirements |
| RDC 755/2022 | Establishment authorisation (AFE) |
| RDC 36/2015 | IVD-specific registration and classification |
The ANVISA registration lifecycle
Classification (Class I–IV)
↓
Choose pathway: Notificação / Cadastro / Registro
↓
Prepare technical dossier + GMP compliance (CBPF)
↓
Submit via Peticionamento Eletrônico
↓
ANVISA technical review
↓
Grant of registration (valid 10 years)
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Post-market obligations: PMS, NOTIVISA, labelling, AFE renewal