The Brazilian Health Regulatory Agency ANVISA has issued Normative Instruction No. 426, dated February 13, 2026, establishing the requirements for data submission and management within the Unique Device Identification System SIUD.
This regulation complements RDC No. 591/2021, strengthening the framework for medical device traceability in Brazil.
Key highlights of IN ANVISA 426/2026:
- National UDI Database SIUD: The system is now officially regulated to receive UDI data from holders of sanitary registrations, consolidating a centralized database for medical devices under health surveillance in Brazil.
- UDI Data Transmission: Registration holders must submit at least the UDI-DI Device Identifier, the fixed portion identifying model and manufacturer, to the SIUD. The UDI-PI Production Identifier, containing variable information such as batch, serial number, or expiration date, must be kept in the company’s internal records.
- Accountability and Authorized Operators: The registration holder is responsible for the accuracy of the data transmitted and may authorize third parties to perform submissions on its behalf.
- Publication and Access: Data submitted to SIUD will be published and made available for consultation through ANVISA’s electronic platforms, following the effective date specified in each submission.
- Corrections and Updates: Companies will have a 60-day grace period to correct data after publication. The regulation also provides specific procedures for updates in cases of ownership transfer or product discontinuation.
- Implementation Schedule: Mandatory submission deadlines will follow the timeline set by RDC No. 591/2021, according to the device’s risk class. Voluntary submissions will be allowed before those deadlines.
Why it matters:
The publication of IN 426/2026 marks a milestone in the implementation of Brazil’s UDI system, aligning the country with international best practices in medical device traceability. The regulation enhances patient safety, strengthens post-market surveillance, improves regulatory processes, and increases the global competitiveness of the Brazilian medical device industry.
In summary, this normative instruction brings regulatory predictability, promotes data transparency, and reinforces the integration of all stakeholders in Brazil’s medical device ecosystem
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