Brazil Streamlines Approval Process for Class II Devices

Brazil’s National Surveillance Agency (ANVISA) is eliminating its Cadastro premarket approval pathway for Class II medical devices and in vitro diagnostics (IVDs) and is replacing it with a notification pathway that would no longer require premarket reviews.

ANVISA has also announced plans to replace the Cadastro registration requirements for Class I medical devices and IVDs with a notification-only registration system. The announcement means that both Class I and Class II devices and IVDs will be allowed to be marketed via the notification pathway.

The agency aims to free up its resources to focus on higher-risk devices and to be in alignment with recommendations from the International Medical Device Regulators Forum.