March 27, 2026
By Priscila Sanada, Luiz Levy and Evangeline Loh
ABIMED ANVISA presentation
On February 27, 2026, ABIMED hosted the regulator ANVISA and its new management team. This included a presentation by the new ANVISA Director, Marcelo Mario Matos Moreira as well as by the General Manager for Medical Devices (GGTPS), Vivian Oliveira.
ANVISA’s objectives for 2026
Director Moreira recognized the need for regulatory transparency and predictability and welcomed feedback from industry. In addition to ANVISA’s Regulatory Agenda for the 2026-2027 year, Director Moreira, emphasized the three pillars of his directorate: transparency clear timelines, review focused based on risk, and international convergence. He briefly elaborated on ANVISA’s objectives: Reduce review timelines, group similar applications for simultaneous assessment, expand the list of Equivalent Foreign Regulatory Authority (AREE), support in terms of artificial intelligence (AI), software as a medical device (SaMD) and the quality of submissions and training for technical staff.
Outcomes from AREEs
Director Moreira noted that regulatory reliance and the use of Normative Instruction 290/2024 are not meeting ANVISA’s expectations. The agency anticipates that approximately 30% of registration submissions should leverage an AREE; however, current data indicates that this target is not being met. In response, ANVISA is evaluating potential changes to the list of AREEs, including the possibility of expanding the authorities recognized under this pathway.
Medical device action plans
The Manager of GGTPS, Manager Oliveria, presented 10 actions. Many of the actions relate to review times for medical devices that are materials and reviewed by GEMAT, as these registros have a review delay of greater than 300 days.
Concluding remarks
Brazil remains an important and expanding market for global medical device manufacturers. These actions presented by ANVISA represent a commitment to efficiency, transparency and international alignment. Emergo believes that an important update would be the inclusion of Europe to the list of AREE if a device is MDR certified. With the EU-Mercosur Partnership Agreement (EMPA) formally signed on Jan. 17, 2026, establishing strengthened regulatory cooperation and alignment frameworks between the blocs, it would be an important update to help ANVISA with the high volume of regulatory applications that the agency and especially its GEMAT division receive from the market.
