ANVISA Cancels In Vitro Medical Devices That Failed to Meet Reclassification Deadline
QR Group warns of the impact of non-compliance with the requirements of RDC 36/2015 and guides companies on how to keep their records in compliance In July 2025, ANVISA announced the cancellation of registrations of medical devices for in vitro diagnosis (IVD) that did not meet the deadline for sanitary reframing, established by RDC No. […]
Medical Device and In Vitro Diagnostic Registration: The Complete Guide for Foreign Manufacturers in Brazil
Understand how ANVISA regulations affect the registration of medical devices and in vitro diagnostics and how QR Group can help with compliance. Brazil, the largest medical device market in Latin America, offers great growth opportunities for international manufacturers. However, the regulatory process for medical devices and in vitro diagnostic products requires detailed attention to ANVISA […]
Anvisa Prioritizes Registration of Tests for Arboviruses, Including Dengue and Chikungunya
Anvisa is implementing measures to speed up the registration of diagnostic tests for mosquito-borne diseases, aiming at better control of arboviruses in Brazil. The National Health Surveillance Agency (Anvisa) recently announced that it will prioritize the analysis of requests for registration of tests for the diagnosis of mosquito-borne diseases, such as dengue, chikungunya and oropouche […]
