Notificação vs. Cadastro vs. Registro

BR-unique

Brazil's three-tier registration system (Notificação, Cadastro, Registro) differs significantly from EU MDR (Declaration of Conformity, EU Declaration of Conformity, full technical dossier submission), US 510(k)/PMA, and other regulatory frameworks, requiring distinct compliance strategies. 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

1. Classify your device (Class I–IV) using the ANVISA catalogue and RDC 751/2022 rules.
2. Map the class to the pathway above.
3. Prepare the technical dossier appropriate for the pathway.
4. Submit via Peticionamento Eletrônico.

Official resources

• RDC 751/2022
• ANVISA — Peticionamento Eletrônico

Device classification is determined by consulting the ANVISA device catalogue (Catálogo de Produtos para Saúde) or by applying the classification rules in RDC 751/2022 Part 2. If classification is uncertain, applicants may formally request a preliminary classification opinion from ANVISA prior to full registration submission.