Access to the Brazilian market

The registration of medical devices in Brazil is regulated by the Agência Nacional de Vigilância Sanitária (ANVISA)and follows two main pathways:

• Notification for low-risk devices (Class I and II)

• Registration for high-risk devices (Class III and IV)

Foreign manufacturers must appoint a local Brazilian Registration Holder (BRH) to manage the application and act as their representative in Brazil.
Notification does not require a full technical review by ANVISA. The BRH submits the application and supporting documents to ANVISA, while the complete technical dossier must be kept available for ANVISA’s inspection at any time.

Registration, on the other hand, requires submission of the complete technical dossier as part of the application, and a B-GMP certificate (with ANVISA audit) or, alternatively, an MDSAP certificate is mandatory.