Brazil ANVISA Regulatory Watch for Medical Devices and IVDs: November 2025

Brazil remains an important Latin American market for medical devices and IVDs. Registration readiness depends on a clear product classification, a controlled technical file, and an early understanding of local submission and post-market responsibilities.

What to review

• Product classification and the applicable ANVISA registration or notification route.
• Product labelling, instructions for use, technical documentation, and quality evidence.
• The process for complaints, adverse events, corrective actions, and change assessment.

Practical impact

Manufacturers should map source documents to the Brazilian submission package before translation and legalisation activities begin. This helps identify gaps in product evidence, QMS records, and local administrative data.

Source to monitor

Refer to ANVISA medical devices information for current notices and regulatory materials.