ANVISA, Brazil’s medical device market regulator, has announced new clinical evaluation requirements that are applicable to all novel medical devices, as well as those high-risk medical devices currently subject to ANVISA’s clinical investigation requirements.
According to a recent summary of the changes issued by the Emergo Group, the new clinical evaluation requirements mandate that clinical data must be obtained from pivotal studies for the specific device being submitted for review, and that such studies have been conducted according to Good Clinical Practice (GCP).
All pertinent clinical evaluation data must be presented to ANVISA at the time of the device submission. Failure to do so will result in a rejection of the device.
Read the full list of new requirements from ANVISA here (in Portuguese).
