ANVISA has issued new regulations about economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products. The regulation, RDC 478/2021 (link in Portuguese), slated to take effect April 1, 2021 revokes 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.

ANVISA identifies 13 device types (link in Portuguese), falling under RDC 478/2021, including implantable defibrillators, cardiac valve prostheses, arterial stents and pacemakers. Data pertaining to price and technical specifications of these devices must be provided to ANVISA according to the following timeframes:

• For new registrations, submissions are required within 60 days of registration publication by ANVISA.
• For existing registrations, submissions are required either upon renewal of those registrations or 60 days following ANVISA approval of a device modification, whichever comes first.