Brazil’s National Agency of Health Surveillance (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC No. 423/2020). The new resolution declared the elimination of the Cadastro registration pathway for Class II medical devices and IVDs and substituted the same with a notification registration pathway (Notificação). The main goal of this new resolution is to further concentrate on high-risk medical devices and IVDs.

Medical devices are evolving and embracing the technologies, so are the Regulatory pathways to govern them. To add to the same, the Brazilian national Health Authority – ANVISA, has published a guidance dedicated to the software with the intended medical purpose (Software as Medical Device – SaMD). The new guidance is aimed at preventing or mitigating the risks associated with the use of medical software and ensure the safety and performance of the SaMD in the Brazilian market.

The new guidance document focuses on: