Brazil - Anvisa Draft Update in the Regulation for Risk Classification, Notification, Registration and Registration Control Regimes, Labeling Requirements and Instructions for Use of In Vitro Diagnostic Medical Devices, Including Their Instruments.

​The Brazilian Health Regulatory Agency (Anvisa) issued the Public Consultation No. 734 of October 22, 2019, to update the regulation for risk classification, notification, registration and registration control regimes, labeling requirements and instructions for use of in vitro diagnostic medical devices, including their instruments according to Anvisa Resolution RDC No 36 of August 26, 2015.

Contributions are accepted by filling in the specific form in the Anvisa Public Consultation Contributions link between October 30 and December 30, 2019.