Are you ready for Australia’s...

The Therapeutic Goods Administration’s (TGA) June 2026 guidance provides detailed information on complying with Australia’s Unique Device Identification (UDI) requirements; compliance dates and transition arrangements are covered separately by the TGA (Figure 3, page 10). 

Does your business manufacture medical devices for supply in Australia? If so, this will be important to you.

Australia’s Therapeutic Goods Administration (TGA) is implementing Unique Device Identification (UDI) regulations to strengthen patient safety and improve medical device traceability. UDI enables more accurate identification of devices, supporting faster action when a product is subject to a safety alert or recall.

UDI compliance is about more than adding a barcode. It brings together globally unique device identification, compliant labelling and packaging, and accurate device information in the Australian UDI Database (AusUDID). Manufacturers and their Australian sponsors have complementary responsibilities for putting these requirements into practice. UDI obligations apply alongside, not instead of, existing Australian regulatory requirements.

Implementation is phased. Standard UDI labelling and database requirements for Class III and Class IIb medical devices commenced on 1 July 2026, subject to applicable transitional arrangements. New Zealand manufacturers supplying Australia should assess their readiness now.

What devices are affected?

UDI requirements generally apply to specified classes of medical devices and in vitro diagnostic devices (IVDs) supplied in Australia and included in the Australian Register of Therapeutic Goods (ARTG), unless an exemption applies. The scope depends on the device’s Australian risk classification.

Detailed information can be found in the TGA’s guidance document Complying with the Unique Device Identification timeframes for medical devices. The table below sets out the key dates relevant to each medical device class.

Devices in scope	Standard start date for UDI labelling and UDI record submission requirements
Class III and Class IIb medical devices	1 July 2026
Class IIa medical devices	1 July 2027
Class Is medical devices—Class I supplied sterile	1 July 2028
Class 3 and Class 4 IVDs	1 July 2028
Class 2 IVDs, and Class 1 IVDs that are instruments or software	1 July 2029

These are standard commencement dates, not a complete assessment of a specific device’s deadline. Transitional arrangements apply to eligible existing devices and certain devices supplied under European legacy certificates. Direct marking, where required, has separate compliance milestones.

Class I non-sterile, non-measuring medical devices and Class I measuring devices do not need to meet UDI requirements. Other exemptions include in-house IVDs, TGA-defined custom-made medical devices and certain devices exempt from ARTG inclusion. For Class 1 IVDs, only instruments and software are in scope.

Importantly, a device made for an individual patient is not automatically exempt. The TGA distinguishes between custom-made, patient-matched and adaptable medical devices. Manufacturers should confirm which regulatory definition applies and whether any ARTG exemption or transitional arrangement is relevant.

GS1 as an issuer of UDI

GS1 is one of the TGA’s recognised UDI Issuing Agencies. The TGA accepts the GS1 Global Trade Item Number (GTIN) as the device identifier within a UDI.

A note for companies using GTINs to identify medical devices for sale in the U.S market

As per our Terms and Conditions (Section 8.1 (b)), we require companies currently using, or intending to use, GTINs (barcode numbers) to identify medical devices for sale on the U.S market to advise GS1 New Zealand and to keep this information up-to-date. GS1 NZ is required to report this information to the FDA.

If you are looking to do so, we kindly ask you to complete the UDI Declaration Form.

GS1 is an accredited issuing agency of Unique Device Identifiers (the GTIN and barcode) for the United States Food and Drug Administration (FDA).

What is UDI?

Unique Device Identification has two components:

UDI-Device Identifier (UDI-DI): identifies the manufacturer and the device. When using GS1 standards, this is the GTIN. Different versions of a device require different UDI-DIs, even when they sit under the same ARTG inclusion.

UDI-Production Identifier (UDI-PI): identifies relevant production details, such as the batch or lot number, serial number, expiry date or software version. The information required depends on the device and its labelling. The manufacturer creates this component using its production information and the coding standard of its chosen issuing agency; it is not a separate number issued by GS1.

These details are carried in a GS1 DataMatrix or GS1-128 barcode, alongside the required human-readable information.

The TGA accepts UDI carriers that meet United States or European Union requirements where the identifier comes from a recognised issuing agency, and the label also meets Australian regulatory and labelling requirements.

However, an accepted barcode and label does not remove the need to meet Australia’s AusUDID database obligations.

What should NZ manufacturers of Medical Devices do now?

Confirm which products and deadlines apply.
Review the device models you supply, or intend to supply, in Australia with your regulatory team and Australian sponsor. Record each device’s classification, ARTG status, applicable exemptions and compliance milestones. Treat this as a product-by-product assessment rather than assuming the same requirements apply across your entire range.

Review identifiers, labels and packaging.
Check that your identifier allocation covers each device model and every applicable packaging level. All packaging levels require their own unique device identifiers. Logistics-only shipping units are excluded. Assess whether a Unit of Use identifier is needed for devices supplied together without individual UDI labels. Reusable devices intended for reprocessing and use on different patients may also require permanent direct marking, subject to the TGA’s specific rules and exemptions.

Prepare accurate device data.
Use the Australian UDI Data Dictionary to identify the mandatory and conditionally mandatory information required for your devices. Check that your records are complete, consistent and suitable for submission. The AusUDID stores device identifiers and associated device information—not individual UDI-PI values or patient information.

Agree responsibilities with your Australian sponsor.
Decide who will provide the device data, submit the UDI records and maintain them over time. Manufacturers can submit device information, but the Australian sponsor must add sponsor-specific information and link the record to the relevant ARTG inclusion. The sponsor remains legally responsible for its associated AusUDID records. Submission and ARTG linking must be completed within 30 days of first supply in Australia after the applicable UDI compliance start date.

Build UDI into ongoing change management.
UDI is not a one-off labelling exercise. Changes to attributes such as brand name, model or device count can trigger a need for a new UDI-DI and a new database record. Establish processes to assess product changes, notify your sponsor and keep AusUDID information accurate and up to date.

Speak with GS1 New Zealand about applying GS1 identification and barcode standards to your UDI implementation. GS1 NZ supports the use of these standards in healthcare, helping manufacturers connect product identification with their UDI requirements.

This article provides general education based on the TGA’s June 2026 guidance, with implementation dates from its separate timeframe's guidance. It does not replace current TGA guidance or device-specific regulatory advice.