ANVISA vs. TGA · FDA · CE MDR · Health Canada · HSA
This page provides a high-level comparison of ANVISA's medical device regulatory framework with other major regulators.
Framework comparison
| Feature | ANVISA (Brazil) | FDA (US) | EU (MDR) | TGA (Australia) | Health Canada | HSA (Singapore) |
|---|---|---|---|---|---|---|
| Risk classes | I, II, III, IV | I, II, III | I, IIa, IIb, III | Class I–III (ARTG) | Class I–IV | Class A–D |
| Pre-market review | Notificação/Cadastro/Registro | 55 (renewable)(k)/De Novo/PMA | CE certification | TGA conformity assessment | Licence application | HSA application |
| Registration holder | Importer Manufacturer or (typically importer for imported devices) | Manufacturer (direct) | Manufacturer (via EU rep) | Sponsor | Manufacturer/importer | Importer/manufacturer |
| GMP requirement | CBPF (RDC 752/2022) | QMSR (21 CFR Part 820) | ISO 13485 / MDSAP | ISO 13485 / TGA audit | ISO 13485 / MDSAP | ISO 13485 |
| Registration validity | 10 years | Indefinite (subject to changes) | Certificate: 5 years | ARTG: indefinite | Licence: varies | Registration: varies |
| Language requirement | Portuguese (Brazil) | English | English/national language | English | English/French | English |
| IMDRF member | Yes (full, since 2020) | Yes | Yes | Yes | Yes | Yes |
| MDSAP participation | No | Yes | No (some CBs) | Yes | Yes | No |
Leveraging existing regulatory approvals for Brazil
| Existing approval | Benefit for Brazil |
|---|---|
| FDA 510(k) or PMA | Clinical data, technical documentation largely reusable |
| CE MDR certificate | CER, essential requirements checklist, ISO 13485 — all reusable |
| TGA registration | Strong basis for ANVISA clinical evidence section |
| Health Canada licence | Useful supplementary evidence |
Always adapt documentation to ANVISA's specific format requirements and translate all submissions into Portuguese.
Verify all information against official ANVISA sources before making regulatory decisions.
Brazil uses three pathways depending on device risk class: Notificação (Class I low-risk devices), Cadastro (Class I devices and some exempt devices), and Registro (Classes II, III, and IV). Each requires progressively more extensive documentation.
For FDA: 510(k) clearances and PMAs remain valid indefinitely unless the manufacturer withdraws them or FDA takes regulatory action. Devices must continue to comply with applicable regulations. For TGA: ARTG registrations remain valid indefinitely unless voluntarily withdrawn or cancelled by the sponsor. The lack of a fixed expiry date contrasts with ANVISA's 10-year renewal requirement.