Jul 24, 2019
Brazilian medical device market regulator ANVISA has begun requiring manufacturers and sponsors to provide field safety corrective action information via an electronic petitioning system.
According to an ANVISA announcement, companies whose medical devices or IVDs are involved in adverse events or other incidents must now submit FSCAs through the agency’s online system, Sistema Solicita (links in Portuguese). ANVISA is no longer accepting hard copies or email submissions.
ANVISA shares tweaks to upcoming regulatory pathway for custom-made medical devices
Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements. Below, we’ve compiled several important Brazilian market and regulatory news items from the past several months.