Mar 11, 2020
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.
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:
The government announcement also stated that all medical device changes must be conducted in compliance with Brazilian Good Manufacturing Practice (BGMP).
RDC 340/2020 and IN 61/2020 were approved on March 3 and will take effect on April 1. They were drawn up after a period of public consultation and based on input from several Brazilian associations of medical device manufacturers and importers.
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