Registro — Class III & IV Devices
The Registro pathway is required for Class III and Class IV devices — the most rigorous ANVISA pre-market pathway. Timelines: Class III 12–24 months; Class IV 18–36 months.
Required documentation
| Module | Content |
|---|---|
| Device identification | Full description, models, accessories, intended use |
| Essential requirements | Checklist against RDC 751/2022 Annex II |
| Risk management file | Full ISO 14971 report |
| Clinical/performance evidence | CER, clinical data, equivalence analysis |
| Biocompatibility | ISO 10993 series (where applicable) |
| Sterilisation | Validation data (where applicable) |
| Software documentation | IEC 62304 (where applicable) |
| Labelling and IFU | Brazilian Portuguese; RDC 754/2022 |
| GMP compliance | CBPF certificate |
| FSC | For imported devices |
| Post-market plan | PMS plan outline |
Review stages: Administrative check → Technical review → Exigências → Decision → DOU publication.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.