ANVISA launches public call notice regarding borderline product classification

On August 8, 2025, the Brazilian Health Regulatory Agency (ANVISA) published Public Call Notice No. 9/2025, inviting stakeholders to submit contributions on the partial Regulatory Impact Analysis (RIA) report concerning classification procedures for borderline products, listed as Subject No. 1.25 of the 2024-2025 Regulatory Agenda.

Borderline products are those whose classification may be unclear within ANVISA’s traditional regulation categories of medicines, cosmetics, medical devices, or foods. The specific or innovative particularities of these products make them more challenging to classify and legitimize.

The public call is aimed at obtaining contributions to help finalize an RIA report that will steer ANVISA’s actions on this matter.

 Among ANVISA’s key targets in revising current procedures are:

• Establishing technical requirements for classification requests, aiming to improve process efficiency and reduce response times;
• Creating a public repository of classification decisions that can serve as a reference for the regulated sectors;
• Providing guidelines for classifying borderline products; and
• Structuring a workflow with clear timelines and roles that ensure certainty and organization in each process.

Stakeholders may submit contributions by August 26, 2025, through ANVISA’s online form.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.