Cadastro — Class II Devices
The Cadastro pathway applies to Class II devices. Requires abbreviated technical documentation and ANVISA simplified review (3–6 months).
Required documentation
| Document | Notes |
|---|---|
| Device description and intended use | Including photographs and diagrams |
| Classification justification | Catalogue reference or rules analysis |
| Essential requirements checklist | Against RDC 751/2022 Annex II |
| Risk management summary | ISO 14971 approach |
| Labelling and IFU (Portuguese) | Compliant with RDC 754/2022 |
| CBPF GMP certificate | From manufacturer |
| FSC (Free Sale Certificate) | Required for imported devices |
Cadastro is valid for 10 years. Post-registration changes require a Petição de Alteração.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.