Australia has officially joined the global Unique Device Identification (UDI) movement, and for those of us who follow UDI developments closely, this is a milestone worth noting. It’s not just another regulatory requirement – it’s part of a global shift toward better transparency, stronger post-market surveillance and improved patient safety.
The Therapeutic Goods Administration (TGA) has designed a system that aligns closely with its international counterparts while tailoring certain aspects to fit Australia’s national regulatory context.
And the conversation is heating up – just last month at the Australia Regulatory Device Summit 2025, TGA representatives shared insights on the new UDI requirements, and explored the challenges and opportunities of aligning UDI systems globally. Read on to grasp the essence of Australia’s UDI framework.
The fundamental principles of the TGA’s UDI system align with the established international model: a two-part UDI composed of a Device Identifier (DI) and a Production Identifier (PI), assignment through a recognised issuing agency, application of the UDI in both human-readable (HRI) and machine-readable (AIDC) formats, and the database submission requirements – showing consistency with the globally adopted systems.
While based on the IMDRF (International Medical Device Regulators Forum) UDI guidance, the Australian system is closer to the US model than the EU counterpart. There’s no Basic UDI-DI, GMDN is the mandated nomenclature, and the database focuses on device and party identification.
Some low-risk devices are exempt – most class I medical devices (unless sterile) and certain class 1 IVDs.
We’ve already seen that some aspects of UDI systems vary by jurisdiction in ways that affect the implementation. The result is that while a manufacturer can often build a single global UDI coding system, they need to adapt their scope, records, database submission processes, and timing to meet the nuanced demands of each market. Australia is no exception.
Manufacturers and sponsors are the central players responsible for UDI compliance under Australian law.
Manufacturer’s duties start with selecting a TGA-recognised issuing agency and allocating product identifiers in line with the relevant specifications. Then, the UDI carrier is applied on the device label, directly on the device itself if applicable, and on all higher levels of packaging. It’s essential that the UDI carrier build and appearance follow the respective coding standard. Manufacturers need to maintain the UDI lifecycle and determine when a new DI is required. The UDI and related data must be submitted to the Australian UDI Database (AusUDID), either directly or via the sponsor.
Sponsors need to make sure that the manufacturer has assigned and applied the UDI correctly. AusUDID submissions and maintenance of records are also within their scope. In cases where a device is supplied by multiple sponsors within Australia, each sponsor is individually responsible for UDID submissions.
The system in Australia allows a third party to assist either with application of the UDI carrier, or data submission to the AusUDID. However, the responsibilities remain with the original stakeholder: the manufacturer retains responsibility for the conformity of the UDI carrier, and the sponsor is responsible for the submitted data.
Importers and distributors play a supporting role in ensuring devices in circulation meet labelling and traceability requirements.
A well-established UDI system allows healthcare providers and regulators to benefit from easier identification and tracking of devices and strengthen the surveillance process.
The Australian UDI Database (AusUDID) is the national repository for UDI information. Think US GUDID, but with Australian practicalities taken in. Required data elements include device identifiers, device information, clinical characteristics, manufacturer and sponsor information, and production data, a.k.a. types of PI.
While the system takes cues from the existing models, it maintains unique features, especially in its link to the ARTG framework. The Australian Register of Therapeutic Goods (ARTG) is the database of medical devices legally supplied in Australia. Every device submitted to AusUDID must be linked to at least one valid ARTG entry. No ARTG, no public listing – AusUDID’s built-in look-up feature validates that given entry exists in the ARTG and is an active inclusion. Manufacturer ID and sponsor ID also need to match between the AusUDID and ARTG records.
Submitting UDI data to the AusUDID isn’t a one-size-fits-all process – we’ve got a few options. Submitters can choose from the following methods to enter data:
M2M can be performed using two different routes – one of the options involves XML files complying with HL7 SPL standard, the same format as for the US GUDID. The other route (and here’s where it gets interesting) is using GS1’s National Product Catalogue (NPC).
TGA is the first regulator to name an existing GS1 solution as an option for data transfer. The NPC, operated by GS1 Australia and GS1 New Zealand, is a certified data pool that is part of a global network, the GS1 Global Data Synchronisation Network (GDSN). If your devices are already in the GS1 NPC, your data gathering and submission process just got a whole lot easier.
Even the bulk upload is a smoother ride than in some other jurisdictions (EUDAMED, swissdamed), since Excel requires less data manipulation than XML. In short, Australia has given us some more user-friendly ways to get UDI data into the system.
High-risk devices go first, starting with class III and IIb devices mid next year. Direct Marking for reusables has the longest runway:
UDI compliance dates | MDs
UDI compliance dates | IVDs
Here’s the big one: class III and IIb medical devices manufactured and labelled before 1 July 2026 and remaining under the sponsor’s control on or after 1 July 2029, have to get relabelled to comply with UDI.
“Under sponsor control” means stock not yet distributed (inventory available overseas, onshore or with the sponsor). Once it’s with distributors, hospitals or patients, it’s considered outside of sponsor’s control.
From experience, the best approach is to start early and plan methodically:
✅ Engage with an accredited UDI issuing agency early
✅ Analyse your device portfolio, consider TGA’s compliance flowcharts and issuing agency’s allocation rules
✅ Assign DIs, plan for PI inclusion
✅ Review the AusUDID Data Dictionary, ensure all fields are captured, consider data sources and data validation
✅ Map your ARTG entries to DIs, cross-reference ARTG ID → device variants → assigned DIs
✅ Update labels and packaging with UDI in both human-readable and barcode formats
✅ Establish internal processes to manage UDI lifecycle, capture allocation, placement, changes and discontinuation
If you aim at getting UDI right, now’s the time to dive in.
The TGA did a great job setting up their UDI information hub, which includes flowcharts, checklists and informational videos. Still, implementing a UDI system can be a demanding program, involving considerable number of resources.
If you're navigating TGA compliance, AusUDID entry, or harmonizing with FDA/EU requirements, consider engaging with our regulatory experts for implementation support.
TGA UDI hub | https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub
AusUDID Data Dictionary | https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/udi-resources-and-technical-documents/australian-udi-data-dictionary
GS1 Australia UDI for Medical Devices | https://www.gs1au.org/industries/healthcare/medical-devices
GS1 Australia National Product Catalogue (NPC) | https://www.gs1au.org/services/data-and-content/national-product-catalogue
IMDRF UDI system Application Guide (IMDRF/UDI WG/N48 FINAL:2019) | https://www.imdrf.org/documents/unique-device-identification-system-udi-system-application-guide