Opportunity: ANVISA to select innovative medical device projects for regulatory assessment

The Brazilian Health Regulatory Agency (ANVISA) issued a public call to select innovative medical devices for a collaborative regulatory assessment project. The initiative aims to advance interactions between ANVISA and companies, startups, and other developers while their products are still in development, rather than when they apply for regulatory approval.

ANVISA aims to make the regulatory process more predictable, especially considering technological advances in AI, new biomaterials, and advanced monitoring systems.

This is a strategic opportunity for innovative companies in the sector, particularly in areas of high technological and regulatory complexity. Early engagement with ANVISA during product development can reduce regulatory uncertainty, align technical expectations, and anticipate potential marketing authorization requirements. In addition, participating in the project can help refine applications and promote the efficient introduction of innovative technologies into the Brazilian market.

The selection builds on ANVISA’s 2023 pilot project, which received more than 100 proposals and selected 10 projects. Projects must meet all the eligibility criteria outlined in the call for proposals:

• fitting into the highest regulatory risk classes (III or IV);
• offering more efficient prevention, treatment, diagnosis, monitoring, mitigation, or cure potential than existing alternatives;
• having no comparable therapeutic or diagnostic alternatives approved by ANVISA;
• being recommended for life-threatening, debilitating, or irreversible diseases;
• having a technological readiness level equal to or higher than TRL-5, where practical tests are closer to real-world conditions of use; and
• having an appropriate team and infrastructure to conduct clinical investigations and develop products that can be regulated by Anvisa.

Up to ten projects may be selected, and five spots must prioritize Brazilian developers. Companies may apply through the form provided by Anvisa by September 3, 2026.

Demarest’s Life Sciences and Healthcare team is monitoring developments and remains available to provide further clarification.