ANVISA comes up with a new resolution, RDC 751, effective from March 01, 2023. The Resolution defines the risk classification rules for medical devices, labeling requirements and Instructions For Use (IFU), and the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices. It revokes RDC no. 185/2001, RDC no.15/2014, and RDC no. 40/2015. Here is the gist of the latest Brazilian regulation.

Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.