Sep 18, 2015

Along with recent major changes to medical device registration and quality system requirements in Brazil, regulators in that country have also significantly reformed oversight of in vitro diagnostic devices.

New IVD regulation RDC 36/2015 and guidance IN 3/2015 (links in Portuguese) include changes to how IVDs are classified and grouped.

Some IVD products such as personal-use blood glucose monitors have been reclassified from Class II to Class III. Reclassification of these IVDs into the high-risk category means these products will have to meet Brazilian Good Manufacturing Practice (BGMP) quality system requirements; manufacturers of affected IVDs will now face additional costs and requirements in order to obtain ANVISA approval.

In addition, ANVISA will now require technical dossiers for all classes of IVDs. Technical dossiers for Class II, III and IV IVDs must be submitted to ANVISA for review.

Some changes, however, are less onerous than current requirements for IVDs. According to IN 3/2015, IVD reagents, calibrators and controls using similar technologies may be grouped together into one product family. Previously, these products each required separate ANVISA registrations.


  • Stewart Eisenhart