How UDI Integrates with TGA Regulatory Processes in Australia

1. Integration with ARTG Inclusion and Variation Processes

When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) or submitting variations (changes to device details, intended purpose, sponsor, etc.), sponsors must provide the UDI Device Identifier (DI) in the application.

• The TGA uses the submitted DI to automatically link the ARTG entry to the corresponding UDI record in AusUDID.
• This linkage ensures that device identification data is consistent across regulatory systems.
• For Class III and implantable Class IIb devices (first mandatory phase from 1 July 2026), UDI submission is required at the time of ARTG application or variation that triggers labelling obligations. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes

2. Annual Device Charges and UDI

Annual charges are payable for devices included in the ARTG. The TGA links annual charge invoices and compliance monitoring to the UDI record in AusUDID.

• Accurate UDI data helps the TGA verify device status and ensure correct charging.
• Sponsors should keep UDI records current to avoid discrepancies during annual charge assessments. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes

3. Incident Reporting and Adverse Events

UDI is required in incident reports submitted under the medical device incident reporting scheme.

• Including the UDI (DI and PI where available) enables faster and more precise identification of affected devices during adverse event investigations.
• This supports better signal detection, trend analysis, and timely safety communications. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes

4. Field Safety Corrective Actions (FSCA) and Recalls

When implementing a Field Safety Corrective Action (including recalls), sponsors must reference the UDI in FSCA notifications and recall actions.

• The TGA uses UDI data from AusUDID to identify the scope of affected devices more accurately.
• This improves the effectiveness of recalls, targeted communications to healthcare providers, and patient-level traceability where feasible. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes

5. Supply Chain and Traceability Benefits

UDI integration enhances supply chain visibility:

• Hospitals, clinics, and suppliers can scan UDI barcodes to record device use and link to patient records.
• In the event of safety issues, UDI enables rapid identification of distribution paths and end-users.
• This supports compliance with global traceability expectations and aligns with IMDRF principles. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes

6. Key Compliance Notes

• UDI data must be submitted to AusUDID before or at the time labelling becomes mandatory for the device class.
• Sponsors are responsible for maintaining accurate, up-to-date UDI records throughout the device lifecycle.
• Changes that affect the DI (e.g., major design change, new version) require a new DI and updated AusUDID record.
• Voluntary early adoption of UDI labelling and data submission is encouraged to prepare for mandatory phases. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes

7. Practical Recommendations

Sponsors should:

• Coordinate UDI assignment early with issuing agencies (GS1, HIBCC, ICCBBA).
• Test AusUDID submissions in the pre-production environment.
• Update internal processes to capture UDI in manufacturing, labelling, and regulatory submissions.
• Monitor TGA announcements for phased implementation updates and guidance revisions.

UDI integration streamlines regulatory interactions and strengthens Australia’s medical device safety framework. For detailed instructions, refer to TGA UDI guidance and AusUDID user resources. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-and-tga-processes