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Your route to Brazil, mapped in 60 seconds.

Answer five questions about your device. See your ANVISA pathway, the certificates and documents involved, and a realistic timeline, based on the regulations in force today.

Tell us about your device

1What are you bringing to Brazil?
2Risk class in Brazil

ANVISA uses four classes (RDC 751/2022). They usually track EU MDR classes; if unsure, choose "Not sure".

3Approvals you already hold
4Do you have a Brazilian registration holder?

A Brazilian company with ANVISA authorization (AFE) must hold the notification or registration.