Introduction
In June 2025, Anvisa officially introduced the Unique Device Identification System (SIUD), marking a significant milestone in the regulation of medical devices in Brazil. This new identifier implements international standards that will revolutionize traceability and product safety in the Brazilian healthcare market.
What is the UDI System?
Definition and Purpose
UDI (Unique Device Identification) is an international standard defined by the International Medical Device Regulators Forum (IMDRF) aimed at enabling the unique identification of medical devices. In Brazil, this system is regulated by RDC 591/2021, which establishes the requirements for the implementation of unique device identification.
Components of the UDI System
The UDI system consists of two main elements:
- Device Identifier (DI): A fixed alphanumeric code that identifies the specific model of the device.
- Production Identifier (PI): Variable information including serial number, lot number, and expiration date.
Regulatory Implementation in Brazil
Regulatory Milestones
The implementation of UDI in Brazil aligns with global best practices of medical device authorities and follows a timeline established by Anvisa’s RDCs. The system applies to different classes of medical devices, including SAMD (Software as a Medical Device).
Key Requirements of RDC 591/2021
The main requirements include:
- Mandatory application of UDI on labels and packaging
- Registration of information in the national database (SIUD)
- Harmonization with international standards
Benefits of the UDI System
For the Industry
Key identified benefits:
- Improved supply chain management
- Easier product recalls and market withdrawals
- Reduced operational costs
- Alignment with international standards
For the Healthcare System
- Complete traceability of medical devices
- Enhanced patient safety
- Easier hospital inventory management
- Integration with health information systems
Implementation Timeline
Phases of Implementation
- Phase 1 (July 2025): Class III and implantable devices
- Phase 2 (2026): Class II devices
- Phase 3 (2027): Class I and SAMD
Company Preparation
Companies in the sector should consider:
- Updating labeling systems
- Staff training
- Implementation of identifier software
International Harmonization
Benefits of Harmonization
- Facilitates medical device exports
- Reduces duplication of regulatory efforts
- Enhances the competitiveness of the national industry
- Strengthens international trust in Brazilian products
Technical and Operational Aspects
SIUD System
The Unique Device Identification System (SIUD) is the national platform that:
- Centralizes UDI data
- Allows queries by health authorities
- Enables real-time traceability
- Integrates with other Anvisa systems
Impact on Health Surveillance
Strengthening Oversight
The UDI strengthens health surveillance through:
- Quick identification during inspections
- Tracking of non-compliant devices
- Improved efficiency in recalls
- Integration with pharmacovigilance systems
Preparing for Compliance
Essential Steps
To ensure UDI compliance:
- Regulatory assessment: Analyze the product portfolio
- UDI issuer selection: Choose a certified issuing organization
- Process adjustments: Modify production lines
- Training: Train internal teams
- Validation: Test systems and processes
Conclusion
The UDI system marks a major advancement in the regulation of medical devices in Brazil, aligning the country with the highest international standards of safety and traceability. Successful implementation requires collaboration between Anvisa, the industry, and medical device consulting service providers.
Next Steps
Companies should begin compliance preparations immediately, considering the deadlines set by RDC 591/2021 and seeking specialized support.
Source: Anvisa – UDI System and Regulatory Updates
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