Anvisa Launches New Call for Regulatory Evaluation of Innovative Medical Devices
The Brazilian Health Regulatory Agency, Anvisa, has published Call Notice 5/2026, inviting developers to participate in a regulatory evaluation project for innovative medical devices in Brazil.
The initiative continues the pilot project launched in 2023, which received 107 proposals and selected 10 projects for regulatory monitoring.
Supporting Innovation in Medical Devices
According to Anvisa, the project is part of the Agency’s effort to address a growing regulatory challenge: the accelerated pace of technological development in health.
The publication highlights medical devices based on new technologies, including artificial intelligence applied to diagnosis, new biomaterials and advanced monitoring systems, which are reaching the market in increasingly shorter cycles.
Preventive and Collaborative Regulatory Dialogue
The initiative allows Anvisa to act in a preventive and collaborative manner.
Instead of identifying regulatory issues only at the time of registration submission, the project enables earlier dialogue and continuous monitoring between Anvisa and developers.
Eligible Projects
Medical device projects classified as risk class III or IV may apply if they represent innovative technology and if there are no comparable therapeutic or diagnostic alternatives approved by Anvisa.
Projects offering significant advantages over existing alternatives are also eligible. Priority will be given to projects developed by national institutions, projects with public funding and projects focused on women’s health.
Selection and Registration Period
The notice provides for the selection of up to 10 projects.
During the follow-up period, Anvisa will maintain continuous dialogue with developers. Registration will be open for 30 calendar days from publication of the notice, through an electronic form available on Anvisa’s portal.
Alignment with Brazilian Innovation Policy
The initiative is aligned with Anvisa’s Innovation Policy, established by Ordinance 1,100/2023, and with the guidelines of the Health Economic-Industrial Complex, established by Decree 11,464/2023.
The objective is to promote timely access to innovative medical devices while preserving safety, efficacy and quality standards established by health regulations.
Impact on Medical Device Manufacturers
For medical device manufacturers and developers targeting the Brazilian market, this initiative represents an opportunity for earlier regulatory interaction with Anvisa during the development of innovative technologies.
Manufacturers and developers should pay particular attention to:
eligibility for risk class III or IV devices;
innovative technological characteristics;
absence of comparable approved alternatives;
potential significant advantages over existing options;
national development and public funding priorities;
projects focused on women’s health;
early identification of regulatory expectations;
continuous dialogue with Anvisa before registration submission.
For developers of innovative medical devices, the new call reinforces the importance of regulatory planning early in the product lifecycle.
