Brazil Mulls Changes to Notification Pathway for Low-Risk Devices

Brazil’s National Surveillance Agency is considering replacing its current registration process for low-risk medical devices with a notification pathway that would no longer require premarket reviews.

“It is our understanding that ANVISA plans to replace ‘Cadastro’ registration requirements for Class I medical devices and in vitro diagnostics with a notification-only registration system,” BMI Research analyst Karen Simpkins told FDAnews.

“However, to the best of our knowledge ANVISA has yet to launch a public consultation on this which would be the normal route prior to enacting a regulatory change. Such a move would be in line with the regulator’s policy of freeing up stretched resources to focus on higher risk devices and align with recommendations from the International Medical Device Regulators Forum.”

Under a notification system, a manufacturer's Brazilian registration holder would electronically submit a minimal amount of information to the agency, with no technical analysis performed, Simpkins said.