SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines
The medical device sector in Brazil has just taken a historic step towards total traceability. During the 2nd Ordinary Public Meeting of the Collegiate Board (DICOL) in 2026, Anvisa approved the Normative Instruction that establishes the rules for SIUD (Unique Medical Device Identification System).
This new regulation is the missing pillar to consolidate RDC 591/2021 and position Brazil as a technological reference in health data management. Understand now what changes for your company and how the Passarini Group ecosystem can assist in this transition.
What is SIUD and what is its role in the regulatory market?
SIUD is Anvisa’s official and public database that will gather all identification information for medical devices commercialized in the country. Structured based on the UDI (Unique Device Identification) concept, the system aims to ensure patient safety and transparency throughout the logistics chain.
Unlike previous systems, SIUD focuses on centralizing concepts, operations, and deadlines, serving as the master data repository for Datavisa.
Data Transmission: Technology and HL7 FHIR API Integration
One of the great highlights of the new Normative Instruction is the modernization of data collection. Companies will be able to transmit data in two ways:
Electronic Form (SOLICITA): Ideal for smaller volumes of products.
API Integration: Using the international HL7 FHIR standard, allowing “machine-to-machine” communication in real-time.
This technological integration requires medical device companies to review their IT and ERP processes to ensure that labeling and identification data are ready for automated submission.
Official Schedule and Deadlines for Adaptation
The new Normative Instruction is scheduled to come into effect on March 1, 2026. From this date, the market enters the official mandatory schedule, staggered by risk class:
- Class IV: September 2029
- Class III: March 2030
- Class II: March 2031
- Class I: March 2032
Although the final deadlines seem distant, the internal structuring of data must begin immediately to avoid operational bottlenecks and compliance errors.
How can the Passarini Group ecosystem help your company?
At Passarini Group, we understand that regulation is only one part of the strategy. Our ecosystem offers an integrated solution (One Stop Shop) so that your company not only complies with the law but also gains efficiency.
We offer support from the technical interpretation of the IN approved in ROP 2/2026 to assistance in structuring files for API integration. Our mission is to transform the regulatory challenge into a competitive advantage for your business.
The future of traceability has arrived. Is your company ready for SIUD?
ANVISA has digitized; your regulatory management needs to keep up. Contact Passarini Group and ensure the efficiency of the new system works in favor of your business.
