On September 15, 2022, the Federal Register published Resolution 751, which deals with risk classification, notification and registration regimes, and the labelling requirements and instructions for the use of medical devices.

This resolution will come into force on March 1, so there is enough time for the productive sector to promote the necessary changes. It addresses issues such as scope, definitions, medical device risk classification, application rules and classification, procedures for notifying or registering medical devices, alteration or modification thereof, revalidation of medical device registrations, information compliance, medical device document repository, procedural reassessment, and administrative sanctions, among others.