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.