Brazil’s UDI: Key Insights for Medical Device Manufacturers

This video explains Brazil’s new Unique Device Identification (UDI) requirements and what manufacturers must do to prepare for compliance under ANVISA’s evolving regulatory framework. Known as SIUD (Sistema de Identificação Única de Dispositivos Médicos), Brazil’s national UDI system is entering its final implementation phase, with the first labeling deadline coming into force on July 10, 2025 for Class IV devices.

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Topics covered in this video include:

• An overview of Brazil’s new UDI framework and deadlines
• Labeling requirements for UDI-DI and UDI-PI, including carriers and formats
• How SIUD works and what data fields must be submitted
• Steps to prepare your product portfolio for compliance
• How Pure Global supports companies with UDI planning, labeling, and SIUD submissions

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Under RDC 591/2021, all medical devices sold in Brazil will need a registered UDI, and RDC 884/2024 has confirmed the phased deadlines for compliance. These are now set by device class: Class IV devices by July 2025, Class III by January 2026, Class II by January 2027, and Class I by January 2028. For reusable devices that require direct marking, the requirement takes effect two years after the respective deadline.

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The video also introduces SIUD, ANVISA’s centralized database, which manufacturers will use to register and manage UDI-DI information. SIUD functions include data submission, updates, and retirement of device identifiers. Each device model must be registered individually, with draft submissions available for 180 days. Manufacturers can grant controlled third-party access, but all changes are traceable.

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With Brazil’s UDI deadlines approaching fast, now is the time for manufacturers to confirm their device classifications, update labeling, validate UDI processes, and prepare to submit data through SIUD. Learn more about medical device labeling in Brazil.

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