Australia UDI Labelling Requirements

Australia’s UDI labelling requirements ensure that medical devices can be accurately identified, tracked, and traced throughout their lifecycle, using both human-readable and machine-readable identifiers.

UDI Carrier Formats:
Each UDI must include two parts:
Human Readable Interpretation (HRI): Clearly printed characters for readability.
Automatic Identification and Data Capture (AIDC): Machine-readable formats like:
1D barcodes

• 2D barcodes (Data matrix)
• RFID tags

Smart cards or biometrics
Manufacturers can choose the most suitable format for their product based on guidance from their Issuing Agency.

Where to Place the UDI:

• On the device label.
• On the device itself (if required).

On all levels of packaging (primary, secondary, tertiary).
Reusable devices must have a UDI marked directly on them unless exempt (e.g., implants or devices used only on the same patient).
Packaging Levels:

• Primary DI: For the base package (lowest trade level).
• Package DI(s): For higher packaging levels like cartons.

Unit of Use DI: For multiple unmarked devices in one package, to track individual items.
Logistics units (shipping cartons, etc.) do not need a Package DI.
Human Readable (HRI) Rules:
Must be placed next to or below the machine-readable AIDC.
Start with the UDI-DI followed by the UDI-PI (Production Identifier).
Non-UDI data should follow the UDI elements, with data delimiters to clarify each part.
Some retail devices may use plain text instead of full HRI formatting.

UDI Triggers:
A new UDI is required when there are significant changes to the device, including:
Safety, performance, or intended use changes.
Changes to indications for use.
Updates to UDI-specific data elements.
These changes indicate a new version or model of the device.
International Labels (EU/US):
Australia accepts UDI labels meeting EU or US standards if:
The UDI is issued by a TGA-recognised agency.
The label complies with Australian regulations.
Australian manufacturers exporting to the EU or US can use the same compliant labels for domestic use, provided the above conditions are met.
Submitting UDIs to the AusUDID is encouraged to minimize confusion for users.
The UDI system improves device traceability, safety, and supply chain transparency, supporting safer patient outcomes and more efficient recalls or adverse event tracking.

Region: Asia

Source: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-information-sponsors-and-manufacturers/udi-labelling-requirements