Brazil’s ANVISA Expedites Approvals for COVID-19 Devices and IVDs

Brazil’s National Health Surveillance Agency (ANVISA) is expediting emergency reviews and approvals for medical devices and in vitro diagnostics (IVDs) related to the COVID-19 pandemic.

The agency is allowing emergency use of information from foreign regulatory authorities that participate in the Medical Device Single Audit Program (MDSAP) in place of its own good manufacturing practice inspections.

For COVID-19 diagnostics, manufacturers can temporarily register their products with limited documents or data, provided they are supported by data that allow the reliability of the results to be evaluated. The products would be registered for a six-month period.