Brazil’s ANVISA now requires electronic submissions of medical device FSCAs

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.

Additional Brazilian medical device and IVD regulatory resources:

• Brazilian medical device vigilance reporting support
• ANVISA medical device and IVD registration consulting
• Brazil Registration Holder (BRH) in-country representation
• Regulatory process chart: ANVISA medical device registration
• Regulatory process chart: ANVISA IVD registration