Brazil – Brazilian regulators update economic monitoring requirements for some medical devices

Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.

The new regulation, RDC 478/2021 (link in Portuguese), repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. The new regulation is slated to take effect April 1, 2021