Brazil – ANVISA will implement new rules for medical device modifications in Brazil

Brazil’s National Health Surveillance Agency (ANVISA) published a new Resolution of the Collegiate Board of Directors (RDC) and a Normative Instruction (IN) with an issuance date of March 6. These regulatory documents will introduce new classification rules for petitions to change medical devices. ANVISA published a news article (link in Portuguese) on their website summarizing the changes and explaining how they differ from current regulations.

Three categories of medical device changes

RDC 340/2020 will classify medical device changes in three categories, according to the type of change requested and the level of risk to health posed by the device’s existing functionality. The categories are as follows…