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 | 510(k)/De Novo/PMA | CE certification | TGA conformity assessment | Licence application | HSA application |
| Registration holder | Importer (typically) | 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.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.