Technical File / Dossier Requirements
The technical dossier (dossiê técnico) demonstrates compliance with RDC 751/2022. All documents must be in Portuguese or accompanied by a certified Portuguese translation.
| Module | Class I | Class II | Class III | Class IV |
|---|---|---|---|---|
| Device description and intended use | ✓ | ✓ | ✓ | ✓ |
| Essential requirements checklist | Summary | Checklist | Full | Full |
| Risk management file | Summary | Summary | Full | Full |
| Clinical/performance evidence | — | Summary | ✓ | ✓ |
| Biocompatibility (ISO 10993) | — | As needed | ✓ | ✓ |
| Sterilisation validation | — | ✓ (if sterile) | ✓ | ✓ |
| Software documentation (IEC 62304) | — | As needed | ✓ (if SaMD) | ✓ (if SaMD) |
| Labelling and IFU (Portuguese) | ✓ | ✓ | ✓ | ✓ |
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.
Key: ✓ = Required in full; Summary = Summary version acceptable; As needed = Only required if applicable to the device. All documentation must be in Portuguese or accompanied by certified Portuguese translation.