Australia’s Unique Device Identification (UDI) Mandate: Immediate Action
The Australian Therapeutic Goods Administration (TGA) has introduced a mandatory Unique Device Identification (UDI) regulatory framework, which came into legal effect on 24 March 2025 through an amendment to the Therapeutic Goods Regulations 2002. This legislative change fundamentally alters the requirements for medical devices supplied in Australia, mandating a rapid, phased approach to compliance.
The urgency stems from the staggered start dates, which prioritise the highest-risk devices:
- Mandatory Start: Compliance is mandatory from 1 July 2026 for high-risk Class III and Class IIb medical devices (labelling and data submission). This initial deadline requires manufacturers to initiate substantial changes to their labelling and data management systems now.
- Voluntary Phase: Manufacturers are currently permitted to voluntarily comply with UDI requirements and submit data to the Australian UDI Database (AusUDID) until 30 June 2026, offering a crucial window for testing and preparation.
- Final Deadline: The full implementation period for UDI compliance runs through to 30 June 2030.
This phased approach is designed to allow manufacturers preparation time but imposes an immediate requirement for strategic planning to ensure traceability for the most critical devices is achieved first.
The Three Pillars of TGA UDI Compliance
Manufacturers supplying devices in Australia must address three concurrent and interconnected compliance requirements:
1. UDI Carrier Placement (Labelling)
The UDI Carrier—typically a barcode—must be affixed to the device label and packaging. For implantable devices, the UDI must also be included on the Patient Implant Card (PIC). The UDI consists of the static UDI-Device Identifier (UDI-DI), which identifies the model, and the dynamic UDI-Production Identifier (UDI-PI), which identifies production-specific data such as batch, lot, or software version.
2. Submission of UDI Data to the AusUDID
The Australian UDI Database (AusUDID) is the central repository for all UDI data, linking it to the device’s entry in the Australian Register of Therapeutic Goods (ARTG). The manufacturer is responsible for obtaining the UDI-DI from a TGA-recognised Issuing Agency, while the Australian Sponsor is responsible for submitting the UDI-DI and related mandatory data into the AusUDID.
The AusUDID features a public-facing ‘production’ environment, which holds current device information freely accessible to the public. This public transparency places a high premium on data accuracy, as any submission errors are immediately visible to patients and clinicians.
3. Direct Marking (DMD)
The most technically challenging requirement, Direct Marking, mandates that the UDI-DI is permanently marked onto the device itself. This applies primarily to reusable devices that undergo cleaning and sterilisation, ensuring the device remains identifiable even if the label is lost. The TGA has granted the longest deadlines for Direct Marking, acknowledging the necessary changes to manufacturing processes.
Detailed Phased Implementation Timelines
The TGA’s timeline prioritises Labelling (Pillar 1) and Data Submission (Pillar 2) due to their importance for immediate traceability. Direct Marking (Pillar 3) is granted a longer lead time.
The regulations came into effect and the AusUDID went live on 24 March 2025. Manufacturers are permitted to voluntarily comply with UDI requirements, including submitting data to the AusUDID, during the initial phase which runs until 30 June 2026.
A. Standard Medical Device UDI Compliance Start Dates (MDR-compliant route)
*Note: The Class IIb Direct Marking deadline of 1 January 2029 is not applicable for implantable medical devices.
B. Transitional Dates for EU MDD Legacy Devices
The TGA provides extended transitional arrangements for devices still being supplied under legacy European Medical Device Directive (MDD) certificates. For example, MDD-certified Class III devices are granted an extension until January 2028 for labelling and data submission.
Strategic Roadmap for Market Access and Ongoing Compliance
The TGA mandates that Class III and Class IIb devices supplied during the transition period and which are still under the Australian Sponsor’s control at the end of that period must be relabelled to meet the UDI requirements. Furthermore, the requirement for Full UDI labelling, which includes existing stock of Class III and Class IIb devices, must be met by 1 January 2030.
The final compliance horizon, where Full UDI compliance—including Full Direct Marking across all applicable device classes—must be achieved, is 1 July 2030. This date marks the end of the transition period and is the target for all compliance pillars across all device classes.
Manufacturers supplying high-risk devices must treat the 1 July 2026 deadline as critical. We offer expert guidance to help manufacturers interpret these complex, class-specific timelines, establish robust data governance for AusUDID submission, and execute both labelling and Direct Marking programmes effectively, ensuring full compliance by the 1 July 2030 deadline.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
