Brazil

Brazil ANVISA Medical Device Registration

The National Health Surveillance Agency (ANVISA) imposes some of the most complex regulatory requirements in South America. Through resolution RDC 751/2022, ANVISA strictly regulates device entry. NKB Regovanta provides dedicated Brazilian Registration Holder (BRH) services and BGMP audit support to ensure successful market entry.

Brazil ANVISA Overview

Brazil’s medical device regulations underwent a major modernization with RDC 751/2022, bringing ANVISA’s framework closer to the EU MDR. Depending on the device class, manufacturers must secure Brazilian Good Manufacturing Practice (BGMP) certification and submit technical dossiers via the Notificação or Registro pathways.

Brazilian Registration Holder (BRH) Mandatory

All foreign manufacturers must appoint a local, legally established entity acting as the Brazilian Registration Holder (BRH). The BRH controls the device registration and interfaces directly with ANVISA. NKB Regovanta provides secure, independent BRH hosting.

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