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January 18, 2026
Approximately 5 minutes
The Australian Unique Device Identification Database (AusUDID)
The Australian Unique Device Identification Database (AusUDID)
1. Purpose and Role
The Australian Unique Device Identification Database (AusUDID) is a publicly searchable database established by the Therapeutic Goods Administration (TGA) to store and make available Unique Device Identification (UDI) information for medical devices supplied in Australia. Its primary objectives are to:
- Improve identification and traceability of medical devices throughout the supply chain
- Support effective post-market surveillance, adverse event monitoring, and targeted field safety corrective actions
- Enhance patient safety by providing accurate and up-to-date device information to healthcare providers, regulators, and the public
- Facilitate Australia's alignment with international standards recommended by the International Medical Device Regulators Forum (IMDRF) https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
AusUDID became operational on 24 March 2025, coinciding with the commencement of the UDI regulatory framework in Australia. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
2. Who Uses AusUDID
- Sponsors (Australian legal entities responsible for devices): Required to submit and maintain accurate UDI records for applicable devices.
- Healthcare professionals, hospitals, and suppliers: Can search the database to verify device details, UDI, and associated information.
- Regulators (TGA and international counterparts): Use data for monitoring, recalls, and safety analysis.
- Public: Limited read-only access to basic device information for transparency.
Access levels vary: Sponsors have full edit/submission rights via TGA Business Services accounts, while general users have read-only search capabilities. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
3. Key Data Elements in AusUDID
Each UDI record includes core data elements aligned with IMDRF Annex A:
- Device Identifier (DI)
- Labeler / sponsor details
- Brand name, version/model
- GMDN code and term
- Risk classification
- Packaging levels (e.g., unit of use, primary, higher levels)
- Production Identifier (PI) attributes supported (lot, serial, expiry, etc.)
- Links to TGA ARTG entry
Records are linked to the Australian Register of Therapeutic Goods (ARTG) for context. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
4. Submission and Maintenance Process
Sponsors submit UDI data through:
- Online portal (individual record entry)
- Bulk upload using the Australian UDI Bulk Upload Template (Excel-based)
Key steps:
- Obtain a UDI from an accredited issuing agency (GS1, HIBCC, or ICCBBA).
- Ensure labelling complies with UDI requirements.
- Create or update records in AusUDID (Production environment).
- Maintain accuracy — changes to device version, packaging, or other attributes require record updates.
Pre-production (test) and production environments are available. Sponsors must test submissions before going live. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
5. Access and User Roles
- TGA Business Services account required for sponsors to log in and manage records.
- Different roles (e.g., Organisation Administrator, UDI Editor) control permissions within a sponsor organisation.
- Public search interface allows anyone to query DI or device details without login.
- Detailed guidance on user roles, login, and environments is provided in supporting documents. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
6. Compliance and Mandatory Requirements
Submission to AusUDID is mandatory for devices subject to UDI requirements, phased by risk class:
- Class III and implantable Class IIb: from 1 July 2026
- Subsequent classes follow in later years, full coverage targeted by 30 June 2030
Records must be submitted before or at the time of mandatory labelling compliance. Sponsors are encouraged to begin voluntary submissions early. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
7. Additional Resources and Support
- AusUDID user guides: login, record creation/editing, bulk upload, user roles
- Technical specifications and data element definitions
- Links to IMDRF UDI guidance and issuing agency standards
- TGA contact for UDI-related enquiries
The database continues to evolve with updates to functionality and guidance. Sponsors should monitor TGA announcements for changes. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/australian-udi-database
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