Australia has officially joined the global movement towards enhanced medical device traceability and patient safety with the launch of its new Unique Device Identifier (UDI) regulatory framework, which went live on 25 March 2025.
This significant step, spearheaded by the Therapeutic Goods Administration (TGA), brings Australia in line with international best practices, promising a safer and more transparent healthcare landscape.
What is the Australian UDI regulatory framework about?
The Australian UDI framework introduces a system for uniquely identifying medical devices throughout their lifecycle. This involves assigning a UDI to each medical device, which is a unique numeric or alphanumeric code comprising two key parts:
- UDI-Device Identifier (UDI-DI): This static identifier is specific to a model of a medical device and acts as the "access key" to information stored in the Australian UDI Database (AusUDID).
- UDI-Production Identifier (UDI-PI): This dynamic identifier provides production-specific information such as the lot/batch number, serial number, manufacturing date, and expiry date.
These UDIs will be present on device labels and packaging in both human-readable and machine-readable formats (e.g. barcodes). The associated UDI data will be submitted to and maintained in the Australian UDI Database (AusUDID), a central repository managed by the TGA.
Who is affected?
The Australian UDI regulatory framework primarily affects manufacturers and sponsors of medical devices supplied in Australia that are required to be included in the Australian Register of Therapeutic Goods (ARTG). This generally applies to most medical devices, with some specific exemptions.
Exemptions include:
- Class I non-measuring, non-sterile medical devices.
- Class I measuring (Im).
- In-house IVDs.
- Custom-made medical devices.
- Patient-matched medical devices with a volume of 5 or less supplied each financial year.
- Devices exempt under the Special Access Scheme (SAS) or Authorised Prescriber Scheme (APS).
- Surgical Loan Kits (SLKs) at kit level.
What are the Australian UDI regulatory framework requirements?
Affected manufacturers will need to comply with several key requirements:
- Obtaining a UDI-DI: Manufacturers must obtain a UDI-DI for each model of their medical device from a TGA-recognised Issuing Agency (e.g., GS1, HIBCC, ICCBBA).
- Formatting the UDI-PI: The UDI-PI must be formatted according to the chosen Issuing Agency's requirements.
- Labelling and Packaging: The UDI carrier (both human and machine-readable) must be included on the device label and all applicable levels of packaging. A "Package DI" may also be required for applicable packaging.
- Direct Marking: For certain devices, particularly those reprocessed between patients, direct marking of the UDI-DI on the device itself may be required, unless it impacts safety or feasibility.
- Submission and Maintenance of Data in AusUDID: Sponsors and manufacturers are responsible for submitting and maintaining accurate UDI and related data in the AusUDID, ensuring it remains up-to-date while the device is in distribution.
What are the implementation deadlines?
The TGA is implementing UDI requirements in a phased approach, providing a transition period for companies to prepare. Mandatory compliance dates are staggered based on the device's risk classification, with high-risk devices having earlier deadlines.
Here's a general overview of the compliance start dates for placing UDI carriers on labels and submitting data to the AusUDID:
- Class III and Class IIb medical devices: From 1 July 2026
- Class IIa medical devices: From 1 July 2027
- Class I medical devices supplied sterile: From 1 July 2028
The introduction of the Australian UDI framework marks a pivotal moment for medical device regulation in Australia. While it presents a significant undertaking for affected manufacturers, the long-term benefits in terms of patient safety, supply chain integrity and global harmonisation are undeniable. By understanding the requirements and planning proactively, we can successfully navigate this new landscape and contribute to a safer future for Australian patients.