TGA Publishes Updated Overview of UDI for Australian Healthcare
The Therapeutic Goods Administration, TGA, has published version 3.0 of “Overview of Unique Device Identification (UDI) for Australian healthcare.”
The document, dated August 2026, focuses on enhancing patient safety through traceability of medical devices.
Purpose of the Document
The document supports education, awareness and adoption of Unique Device Identification, or UDI, across healthcare settings.
It explains key UDI concepts and highlights the benefits of UDI adoption for healthcare provider organisations.
The document is intended for a broad healthcare audience, including executive staff, management, clinical governance, health informatics, clinicians, quality and risk teams, recall coordinators, biomedical engineering, procurement, supply chain, IT, finance and administration.
Australian UDI System
The TGA states that Australia has implemented the UDI system for medical devices.
Under the UDI framework, manufacturers supplying medical devices in Australia must assign a UDI to their devices, include the UDI on device labels and packaging, and submit UDI records to the TGA through the Australian UDI Database, or AusUDID.
The main purpose of UDI is to improve patient safety. When adopted into supply chain, clinical and health systems, UDI enables faster and more accurate identification of devices used on or implanted into patients in the event of adverse events, market actions or recalls.
UDI at a Glance
The Australian UDI system has two key components:
placing UDIs on medical device labels and packaging;
submitting the UDI-Device Identifier, or UDI-DI, and related device data to the AusUDID.
A UDI consists of two parts: the UDI-DI, which identifies the specific model or version of a device, and the UDI-Production Identifier, or UDI-PI, which identifies production details such as batch number, lot number, expiry date, manufacturing date or software version.
The document explains that the AusUDID is a free public database providing information on medical devices approved for supply in Australia. Healthcare professionals can use it to search device information, access clinical characteristics and manufacturer details, and view Patient Information Leaflets or Instructions for Use where available.
Phased Introduction in Australia
The TGA notes that UDI requirements are being introduced in Australia through a phased implementation approach.
Mandatory compliance began on 1 July 2026 for high-risk medical devices and will progressively apply to other device classes until 30 June 2030.
The document also clarifies that some devices may already display a UDI because they comply with UDI requirements in other jurisdictions, such as the United States or the European Union. Australia’s UDI framework recognises US and EU UDI-compliant labels, supporting global harmonisation and improved device traceability.
At the time of publication, there are no mandatory requirements for healthcare providers to adopt UDI, although TGA is working with the Australian Commission on Safety and Quality in Health Care to consider inclusion of UDI in the third edition of the National Safety and Quality Health Service Standards, expected in 2028–29.
Why UDI Matters for Healthcare
The TGA describes UDI as a foundation for safer and more reliable use of medical devices across healthcare.
For healthcare organisations, UDI helps staff identify the right device, record it consistently, locate affected products quickly, and connect device information to patient care, recalls, adverse event reporting, registries and supply chain processes.
UDI supports several patient safety activities, including informing patients about devices used in their care, improving supply chain visibility, identifying alternative products during disruptions, supporting accurate adverse event reports, enabling effective recalls and improving analysis of device performance and patient outcomes.
Preparing Healthcare Organisations for UDI
The document explains that adopting UDI in healthcare affects people, processes and technology across an organisation.
There is no single implementation approach, as healthcare providers operate under different models of care, workflows, systems and business requirements.
Healthcare organisations that prepare early will be better positioned to realise the benefits of UDI, including improved patient safety, enhanced quality of care, more effective recall management, greater supply chain visibility and reduced operational costs.
Recommended preparation activities include understanding the value of UDI, building organisational awareness, assessing systems and infrastructure, developing a staged implementation approach, strengthening scanning and interoperability, validating UDI data and processes, and planning workforce and change management.
UDI and Related Identifiers
The TGA explains that a UDI is assigned using internationally recognised standards managed by recognised issuing agencies.
Australia recognises three issuing agencies: GS1, Health Industry Business Communications Council, or HIBCC, and the International Council for Commonality in Blood Banking Automation, or ICCBBA.
UDIs must be provided in both human-readable and machine-readable forms, such as a linear barcode, 2D Data Matrix or QR code.
The document also explains related identifiers, including the Unit of Use DI for multiple unlabelled devices supplied in a single package and Direct Marking DI for reusable devices reprocessed between uses on different patients.
Regulatory Requirements for Medical Devices
The TGA states that manufacturers and sponsors supplying medical devices in Australia must assign a UDI to devices subject to UDI requirements, place the UDI on device labels and packaging, and submit the UDI-DI and associated device information to the AusUDID.
Sponsors must also use UDI information, where available, in regulatory activities such as recalls and adverse event reporting.
The document also explains UDI Triggers, meaning changes to certain device characteristics that represent a new model of device and require a new UDI-DI. Updated data must be supplied to the AusUDID within 30 days of the newly labelled device being supplied in Australia.
Devices in Scope and Exemptions
Most medical devices and IVD devices included in the Australian Register of Therapeutic Goods, or ARTG, must comply with UDI requirements unless a specific exemption applies.
Requirements are introduced according to risk classification, with higher-risk devices required to comply first.
Examples of exempt devices include Class I non-sterile, non-measuring medical devices, Class Im devices, custom-made medical devices, certain low-volume patient-matched devices, devices supplied under the Special Access Scheme or Authorised Prescriber Scheme, in-house IVDs and certain Class 1 IVDs.
Where Healthcare Will See UDIs
Healthcare professionals may encounter UDIs on device labels, applicable packaging levels, directly marked reusable devices, Patient Implant Cards, equipment identification plates and software screens.
The document states that Patient Implant Cards must include device name, model, manufacturer details, batch, lot or serial number, the UDI-DI in human-readable form and the full UDI, including UDI-DI and UDI-PI, in machine-readable form.
The document also explains where healthcare may not see UDIs, including individual devices supplied in multipacks, Instructions for Use, Patient Information Leaflets and devices where UDI is not yet mandatory due to phased implementation or transitional arrangements.
UDI in Reporting
UDI supports more accurate identification of affected devices during recalls, market actions and adverse event reporting.
Sponsors and manufacturers of medical devices with a UDI must include the UDI in reports, which may include a UDI-DI, UDI-DI and UDI-PI, or multiple UDI-DIs and UDI-PIs depending on the issue.
Device-Specific Considerations
The document includes reference information for multiple device types, including implantable devices, single-use devices, reusable devices, personalised medical devices, dental devices, software, surgical loan kits, system or procedure packs, configurable systems, accessories, retail devices and IVDs.
For implantable devices, the UDI will generally be available on the device label and packaging and may be provided through peel-off labels, tags or other mechanisms to support recording during procedures. Implantable devices are not required to be directly marked with the UDI, but are generally required to include the UDI on the Patient Implant Card unless specifically exempt.
Reusable devices used on multiple patients and reprocessed through high-level disinfection or sterilisation must be directly marked with the UDI.
The document also notes that custom-made medical devices are exempt from UDI requirements, while patient-matched and adaptable medical devices may be subject to UDI requirements depending on their characteristics.
Using the AusUDID
The AusUDID is Australia’s central database for device information and is linked to the ARTG.
Healthcare organisations can use it to look up device information, check clinical characteristics such as MRI safety status, identify manufacturer and sponsor details, and access supporting documents where available. The AusUDID does not contain patient information.
Users can search the AusUDID by UDI-DI, catalogue number, brand name, model name, manufacturer name, ARTG ID, GMDN term, sponsor information or other keywords.
Version 3.0 Updates
The version history states that version 3.0 was updated to tailor content for healthcare audiences, reflect UDI requirements and guidance, clarify UDI requirements and terminology, improve navigation and readability, consolidate duplicate information, add new examples and update links, references and supporting resources.
Impact on Medical Device and IVD Stakeholders
For healthcare providers, medical device manufacturers, sponsors and IVD stakeholders, this updated overview is important because it explains how Australia’s UDI system supports device traceability and safer use across healthcare.
Stakeholders should pay particular attention to:
UDI-DI and UDI-PI concepts;
AusUDID records and public device information;
phased compliance dates through 2030;
healthcare system readiness and adoption planning;
scanning, interoperability and data quality;
UDI use in recalls and adverse event reporting;
UDI requirements for labels, packaging and Patient Implant Cards;
direct marking requirements for reusable devices;
device-specific expectations for implantables, PMDs, software, SLKs, SOPPs and IVDs;
use of UDI information in healthcare systems, registries and patient records.
For organisations in Australia, the key message is that UDI is becoming a central tool for improving patient safety, device traceability, recall management, post-market surveillance and healthcare data quality.
