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January 15, 2026
Approximately 5 minutes
Brazil ANVISA RDC 591/2021: Unique Device Identification (UDI) System for Medical Devices
Brazil ANVISA RDC 591/2021: Unique Device Identification (UDI) System for Medical Devices
1. Purpose and Scope
RDC No. 591/2021, effective January 10, 2022, establishes the Unique Device Identification (UDI) system for medical devices regulated by ANVISA in Brazil. The system enables unambiguous identification of devices throughout distribution and use. It applies to all regularized medical devices, including IVDs, except custom-made devices and those under clinical investigation. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
2. Key Definitions
- UDI: Numeric or alphanumeric code for unique identification, consisting of UDI-DI (Device Identifier, model-specific) and UDI-PI (Production Identifier, e.g., serial/batch number, expiry, software version).
- AIDC: Automatic Identification and Data Capture (e.g., barcodes, RFID).
- HRI: Human Readable Interpretation.
- Issuing Entities: Accredited organizations (GS1, HIBCC, ICCBBA) for UDI generation.
Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
3. Obligations for Manufacturers and Holders
Manufacturers must assign UDI to devices and all packaging levels (except shipping containers) before market placement, using accredited issuing entities. Quality systems must ensure correct UDI assignment. Holders (importers/local responsible) verify compliance and ensure data consistency in the UDI database. For high-risk implants (e.g., coronary stents, hip/knee), UDI must appear on traceability tags. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
4. UDI Composition and Application
UDI comprises UDI-DI (unique per model) and UDI-PI (production controls like serial, batch, expiry, SaMD version). Applied via AIDC and HRI on labels and packaging. Special cases: reusable devices need permanent UDI; single-use low-risk may have UDI on higher packaging. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
5. Labeling Requirements
UDI carrier (AIDC + HRI) must be on device label or packaging, legible throughout lifetime. Exceptions for space constraints, single-use devices, lay-use products (HRI prioritized). RFID requires accompanying barcode. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
6. UDI Database Submission
Holders submit core data (per Annex I: quantity, UDI-DI, production controls, manufacturer details, GMDN code, etc.) to ANVISA's public UDI database before marketing. Updates required for changes. Data freely accessible to public. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
7. Timelines and Transitional Provisions
Phased implementation from effective date:
- Class IV: 2.5 years
- Class III: 3 years
- Class II: 4 years
- Class I: 6 years
Reusable devices: additional 2 years for direct marking. Pre-deadline manufactured devices optional compliance. Database submission starts upon ANVISA publication. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
8. Exemptions and Special Cases
Exempt: shipping containers, certain single-use disposables in kits, orthopedic trays configured per order. In-house low-risk SaMD exempt under separate rules. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
9. Post-Market and Enforcement
UDI required in adverse event/technical complaint/field action reports. Non-compliance constitutes health infraction; possible suspension of sale/import/use. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
10. Practical Guidance for RA Managers
Align with IMDRF principles; select accredited issuer early. Document UDI assignment in QMS. Plan phased compliance by class. Ensure holder-manufacturer coordination for database accuracy. Monitor updates on database launch. Source: ANVISA RDC No. 591/2021 (English translation) (https://cbdl.org.br/wp-content/uploads/2022/05/RDC_591-2021-UDI-Unique-Medical-Devices-Identification-system.pdf)
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