Kathryn Burke, Emergo Group
Brazil’s medical device market regulator, ANVISA, announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of March 1, 2023.
The updates (link in Portuguese) to RDC No. 185/2001 further define the rules for classifying the risk of medical devices, the requirements for labeling and instructions for use and the procedures for notification or registration of medical devices.
The resolution’s major changes include:Adoption of specific classification rules for new technologies including software as a medical device (SaMD) and nanomaterials. The updated classification rules generally align with EU MDR classifications. Consolidation of notification, registration and change rules in a single RDC. Incorporation of rules for the Documentary Repository of Medical Devices. Note: t…