Notificação vs. Cadastro vs. Registro
BR-unique
Brazil's three-tier registration system has no direct parallel in EU, US, AU, SG, or CA frameworks. Understanding which pathway applies is the critical first step in any Brazil market entry strategy.
| Pathway | Applies to | ANVISA review | Typical timeline |
|---|---|---|---|
| Notificação | Class I medical devices & IVDs | Minimal/post-market | Days to weeks |
| Cadastro | Class II medical devices & IVDs | Abbreviated review | 3–6 months |
| Registro | Class III & IV devices & IVDs | Full technical review | 12–36 months |
All registrations are valid for 10 years.
Choosing the right pathway
- Classify your device (Class I–IV) using the ANVISA catalogue and RDC 751/2022 rules.
- Map the class to the pathway above.
- Prepare the technical dossier appropriate for the pathway.
- Submit via Peticionamento Eletrônico.