Oct 23, 2019

Brazilian medical device market regulator ANVISA has issued two new consultations proposing changes to longstanding regulations of medical devices and IVD products.

The regulator will accept comments on the new consultations (link in Portuguese) for a 60-day period before moving ahead with proposed changes.

Changes to medical device classification and related requirements

For medical devices, ANVISA has published Public Consultation 730/2019 to update RDC 185, issued in October 2001. Updates cover classification, registration pathways, labeling requirements and instructions for use. Specifically, ANVISA is proposing closer alignment of Brazilian device classification rules to those in the European Medical Devices Regulation (MDR), as well as a stock depletion allowance to enable manufacturers to sell previous versions of some devices through these products' expiration dates.

Harmonizing Brazil's IVD registration process

ANVISA’s proposed changes to IVD oversight are covered in Public Consultation 734/2019, which would update RDC 36 issued in 2015. The consultation targets classification and notification, registration pathways, instructions for use and labeling requirements for IVDs. The consultation would harmonize ANVISA classification rules for IVDs with international requirements (and IVDR rules, likely), as well as make Brazilian market access less complex for IVD registrants.

Emergo by UL consultants in Brazil will provide further insights regarding potential changes to ANVISA’s medical device and IVD regulations as we learn more.

Additional Brazilian medical device and IVD market resources from Emergo by UL: