About UDI in Australia

The Australian Government is strengthening patient safety by introducing Unique Device Identification (UDI) for medical devices. UDI also supports other medical device reforms designed to improve the effectiveness of the regulatory framework, including the management of post-market safety-related activities, such as recalls.

With the introduction of UDI, Australia will join a globally harmonised approach that supports more accurate tracking and tracing of medical devices (unless the device is exempt).

UDI facilitates traceability through the introduction of a unique identifier. The unique identifier will be a combination of numbers, letters and symbols that show:

• The UDI-Device Identifier (UDI-DI) which indicates the model of medical device
• The UDI-Production Identifier (UDI-PI) which provides the production specific information such as lot or batch number.

The unique identifier can link to and integrate with existing government, clinical, hospital, and industry databases. Device labels and all levels of packaging for that device will be required to show this unique identifier. The identifier will need to be labelled in a way that can be found and read by both people and machines (like a barcode).

The unique identifier will be issued by TGA recognised organisations (Issuing Agencies) that issue UDIs in accordance with global standards. 

Benefits of UDI

Every year, millions of devices are used and/or implanted in patients in public, private and day hospitals and clinics. The ability to accurately identify medical implants has been challenging. It has hampered contacting specific patients when an issue with their implant has been identified.

UDI allows clear and unambiguous identification of medical devices and facilitates access to information about the device. This allows better identification of medical devices within Australia, strengthening patient safety and supporting quicker responses to device safety issues.

Further benefits are shown below:

The Australian UDI Database (AusUDID)

The Australian UDI Database (AusUDID), established by us, will store medical device UDI information for devices supplied in Australia. The data in the AusUDID will link to the relevant inclusion(s) in the Australian Register of Therapeutic Goods (ARTG).

Sponsors and manufacturers will submit and maintain the device data in the AusUDID. Patients, consumers, clinical quality registries and health professionals will be able to access this information for free.

No patient information is collected or stored in the AusUDID. Patient data is managed by hospitals and healthcare providers.

Status of Australian UDI implementation

We have developed the AusUDID in collaboration with many stakeholders including consumer groups.

As the UDI changes to the Therapeutic Goods (Medical Devices) Regulations 2002 are still being defined, we are unable to provide an exact timeframe of when UDI will commence in Australia. 

For more information about the status of UDI in Australia visit UDI: News and updates.

UDI enquiries

In addition to the information on this UDI Hub, we have a dedicated UDI Support Team handling enquiries on the Australian UDI implementation and the AusUDID.

The UDI Support Team provides a range of services including:

• Phone and email support during Australian (AET) business hours for all enquiries on the UDI implementation, operation, and access to the Pre-Production version of the AusUDID
• Developing and distributing information and support documentation
• Maintaining UDI-related information on the TGA website
• Creating supporting documents and guidance on UDI, the AusUDID and including for healthcare providers and professionals.

The UDI Support Team does not replace the medical device information/enquiry lines and support channels already offered by us.

Once finalised, all supporting documentation will be available on our website via the UDI Hub.

How do I sign up to the UDI mailing list?

To sign up to our UDI mailing list, contact the UDI Support Team at UDI@health.gov.au

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