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.
If registration is denied, applicants may file an administrative appeal (recurso) within the timeframe specified in the ANVISA rejection notice. See Appeals section for details.