ANVISA Publishes Preliminary Manual for Brazil’s UDI Medical Device Database

ANVISA Publishes Preliminary Manual for Brazil’s Unique Device Identification (UDI) Database

May 28, 2025 – The Brazilian National Health Surveillance Agency (ANVISA) has released a preliminary manual detailing the operation of its Unique Device Identification (UDI) database. This step brings Brazil closer to international standards for medical device traceability, aligning with the International Medical Device Regulators Forum (IMDRF) and the country’s Resolution RDC 591/2021.

The manual outlines the current functionalities of the UDI database, with additional features still in development. The recent Public Consultation CP 1313/2025, which gathered input from stakeholders, closed on May 26, 2025. The UDI system will become fully operational once the related Normative Instruction (IN) is finalized and enacted.

Principaux points à retenir :

• Purpose of the UDI System: Improve patient safety and enhance regulatory oversight by standardizing medical device identification across Brazil.

• RDC 591/2021: Establishes a national UDI database for all registered medical devices.

• Compliance Deadlines (from the IN’s effective date):

  • Class IV devices: 3.5 years

  • Class III devices: 4 years

  • Class II devices: 5 years

  • Class I devices: 6 years

• Manual Scope: Provides operational guidance for completed features; pending features will be addressed in future updates.

ANVISA is currently reviewing feedback from the public consultation and will proceed to finalize the Normative Instruction. The final version of the UDI manual will be published alongside or shortly after the IN takes effect.

Please ask RegASK to monitor all developments closely and start preparing internally to meet upcoming compliance deadlines once the IN is in force.