RDC 751/2022 — ANVISA's Updated Medical Device Registration Regulation
ANVISA (Agência Nacional de Vigilância Sanitária) regulates medical devices in Brazil under Resolution RDC 751/2022, which consolidated and updated prior regulations governing medical device Registro (Registration), Notificação (Notification), and Cadastro (Listing). Devices are classified as:
- Class I (lowest risk) → Notification (Notificação) — streamlined process
- Class II → Listing (Cadastro) — reduced documentation
- Class III and IV (highest risk) → Full Registration (Registro) — complete technical dossier, clinical evidence, and GMP audit
Key requirements include:
- Brazilian Importer (Importador/Responsável Técnico): Foreign manufacturers must partner with an ANVISA-registered Brazilian company that holds the product Registration in its name.
- Good Manufacturing Practice (BPF/GMP) Certificate: Issued by ANVISA or recognised equivalent — required for Class III and IV products.
- Portuguese-language labelling and IFU: All labelling must be in Portuguese.
- DATAVISA/Solicita portal: ANVISA's electronic submission system for Registro applications and post-market notifications.
📅 Effective / published: 2022 (RDC 751); ongoing updates via ANVISA RDCs and INs
Brazil requires the Brazilian importer to hold the ANVISA Registro — foreign manufacturers cannot hold it directly. Identify your Brazilian importer early, as their ANVISA registration status and GMP certificate directly affect your market access timeline.
View official source (ANVISA — Produtos para Saúde) ↗