Healthcare, Medical Devices, Regulatory Affairs

ANVISA updates economic monitoring requirements for some medical devices

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.
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