UDI Labelling Requirements for Medical Devices in Australia

1. Overview of UDI Labelling

The Therapeutic Goods Administration (TGA) requires sponsors to apply a Unique Device Identification (UDI) to the label of medical devices and higher-level packaging where applicable. The UDI consists of a Device Identifier (DI) and, where relevant, a Production Identifier (PI). This requirement supports global harmonisation with IMDRF standards and improves device identification, traceability, and patient safety. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

The UDI must be included on:

• The label affixed to the device itself (if practicable)
• The primary packaging (immediate container)
• Higher-level packaging (e.g., outer box, case)

The format must be both human-readable interpretation (HRI) (plain text) and automatic identification and data capture (AIDC) (e.g., barcode, 2D symbol). https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

2. Accredited Issuing Agencies and Format Standards

TGA recognises three issuing agencies for UDI:

• GS1 (Global Trade Item Number – GTIN-based)
• HIBCC (Health Industry Business Communications Council)
• ICCBBA (for human cells, tissues, and cellular and tissue-based products – HCT/Ps)

The UDI format must comply with the standards published by the chosen issuing agency and align with IMDRF UDI guidance. Sponsors must select one agency per device version/model. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

3. Presentation Requirements

• HRI — Must be adjacent to the AIDC carrier or, if space is limited, clearly linked.
• AIDC — Barcode or 2D symbol (e.g., GS1 DataMatrix, HIBCC Data Matrix) that encodes the full UDI.
• Both formats must be on the same side of the label/package where possible.
• If the device is too small or has no label, UDI may be placed on higher-level packaging only (with justification). https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

4. Direct Marking for Reusable Devices

For reusable devices that undergo cleaning or sterilisation between uses (e.g., surgical instruments), the UDI must be directly marked on the device itself in a permanent, legible manner. Direct marking requirements are phased:

• Class III and implantable Class IIb: from 1 January 2028
• Other classes follow in subsequent phases.

Exceptions apply if direct marking is not technically feasible (e.g., very small devices). https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

5. Phased Implementation and Compliance Dates

UDI labelling requirements are mandatory in phases based on risk classification:

• Class III and implantable Class IIb — from 1 July 2026
• Subsequent classes (Class IIb non-implantable, Class IIa, Class I sterile/measuring, Class I) follow in later years.
• Full mandatory compliance targeted by 30 June 2030.

Voluntary labelling is permitted earlier. Devices must also have corresponding UDI data submitted to AusUDID by the labelling compliance date. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

6. Exemptions and Special Cases

Certain devices are exempt from UDI labelling:

• Custom-made devices
• Devices intended solely for clinical investigation
• Devices manufactured for export only (in some cases)
• Devices with no labelling space and no higher-level packaging

Special provisions apply to systems/procedure packs, retail devices, and combination products. Sponsors should consult TGA guidance for specific scenarios. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements

7. Practical Considerations

• Labels must remain legible after normal use, storage, and handling.
• Changes to device version, packaging configuration, or other attributes may require updated UDI and labelling.
• Sponsors should coordinate with issuing agencies, printers, and supply chain partners early.
• Non-compliance with labelling requirements may result in regulatory action.

For detailed technical specifications, refer to TGA UDI guidance documents and issuing agency standards. Sponsors are encouraged to prepare well in advance of mandatory dates. https://www.tga.gov.au/products/medical-devices/labelling-and-advertising/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements