Australia’s TGA UDI system: a compliance guide for medical device manufacturers

Author:Sonictec · 2026-10-21 Updated

Australia’s phased mandatory rollout has begun

Australia’s UDI regulations took effect on 24 March 2025. Mandatory labelling and database-record requirements began for Class III and Class IIb medical devices on 1 July 2026, with other classes following later. Manufacturers need to coordinate device identifiers, artwork, packaging levels, production data and their Australian sponsor; this is more than a label-printing task.

UDI identifies device models and production runs to support traceability, recalls and post-market safety. This article draws on TGA guidance checked on 21 October 2026. Standard dates are not necessarily the applicable dates for every device: existing-device arrangements, legacy EU certificates and specific exemptions need individual assessment.

Source:TGA: UDI compliance timeframes

UDI-DI and UDI-PI: separate model and production information

A UDI normally combines a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI). The DI identifies the manufacturer and a particular model or version. Depending on the device, the PI includes production information such as lot or serial number, manufacture or expiry date, or software version. Different batches of the same model generally share a DI and are distinguished by PI; specified device changes may require a new DI.

TGA recognises GS1, HIBCC and ICCBBA as issuing agencies. Manufacturers obtain DIs under a recognised agency’s system and generate PIs using its coding standard. PIs come from actual production data, rather than being issued by the agency for each batch. Maintain a consistent mapping between the Primary DI, Package DIs, Direct Marking DI and Unit of Use DI.

Source:TGA: Getting a UDI and using overseas labels ；TGA: UDI and other device identifiers

Which medical devices and IVDs are in scope

Start with the product’s Australian regulatory status, classification and ARTG inclusion, then assess UDI. The table gives the usual class-based scope; specific exemptions still need checking. Class I, Class Is and Class 1 IVD are distinct classifications, so “Class 1” alone is not enough to determine whether UDI applies.

Common exemptions include devices exempt from ARTG inclusion, in-house IVDs, custom-made devices and qualifying special-access or low-volume patient-matched devices. Devices intended strictly for export from Australia are also outside Australian UDI requirements, although destination-country rules still need checking. Personalised or patient-matched status does not by itself establish an exemption.

Source:TGA: Scope of UDI requirements

Labels, packaging and direct marking

The UDI carrier normally includes both human-readable interpretation (HRI) and automatic identification and data capture (AIDC), such as a barcode or two-dimensional code. Apply it to the device label and applicable higher packaging levels; shipping containers are treated differently. An instruction-for-use entry does not replace the required label or package carrier, and RFID use still requires the appropriate barcode.

Where significant space constraints prevent both HRI and AIDC, the manufacturer must choose an appropriate form for the use environment and retain its justification. If the carrier cannot fit on the base package, the guidance permits placement on the next higher packaging level. These arrangements require a genuine space constraint, not simply an aesthetic preference.

Direct marking primarily concerns reusable devices reprocessed between different patients, with marking durable through intended use and cleaning. Implantable devices do not require direct marking, and specific exemptions cover technical infeasibility or effects on safety or performance. Reuse on the same patient, or capital equipment with labels that remain intact throughout its intended life, should not automatically be treated as requiring laser marking.

Source:TGA: UDI requirements guidance ；TGA: UDI for specific device types

Implementation dates: labelling and direct marking are separate milestones

These are standard implementation dates, excluding legacy EU certificate and existing-device transitions. Once the requirements apply, the AusUDID record must be submitted within 30 days of the device’s first Australian supply after its applicable compliance date. The dates do not mean that every record must be submitted that day, nor does the 30-day submission period extend the labelling deadline.

Implantable devices are exempt from direct marking. Dates follow the class-specific table in TGA’s timeframe guidance V2.1 (June 2026); transitional conditions must also be checked.

Direct marking does not apply to every IVD; assess the device’s use and reprocessing arrangements. The final standard direct-marking milestone is 1 July 2030.

Source:TGA: UDI compliance timeframes

Existing stock and legacy EU certificates: distinguish the transitions

“Existing device” status depends on manufacture and labelling dates, not the age of its ARTG entry. Qualifying existing Class III and IIb devices remaining under sponsor control must be relabelled by 1 July 2029; those returning to sponsor control afterwards must be addressed before resupply. Other qualifying existing devices, including IVDs, are exempt from relabelling for their lifetime; qualifying existing devices are also exempt from direct marking.

Assess sponsor control from the actual possession, supply and use arrangements. Third-party warehousing, consignment and hospital stock cannot be classified solely by location. Retain manufacture dates, artwork versions, batches, quantities, locations and supply status, rather than treating unmanufactured goods or purchase orders as existing stock.

The EU MDD/IVDD arrangements have separate eligibility conditions, including extended certificate validity, Australian supply under the relevant legacy certificate and the transition status. For example, eligible Class III and Class IIb implantable devices may use the 1 January 2028 legacy-certificate date. Devices completing their MDR transition earlier cannot continue relying on that extension. Check both the basis of Australian supply and EU certificate status; a CE mark alone does not establish eligibility.

Source:TGA: UDI compliance timeframes

Implants, medical software and Unit of Use details

Implant UDIs should be identifiable and recordable before implantation, with UDI included on patient implant cards where required. The PI for an active implantable device should contain its serial number; other implants use serial or lot numbers according to the manufacturer’s quality system. Exemption from direct marking does not remove packaging, implant-card or database obligations.

For in-scope SaMD, assign the DI at software-system level and include version information in the PI as required. Electronically supplied software should display a readable UDI in an accessible interface, such as an About page; a barcode is not required for that electronic display. Major revisions affecting safety, intended use, performance or effectiveness may trigger a new DI, requiring more than a version-number change.

Where a base package contains multiple identical devices that cannot be individually labelled or directly marked, a Unit of Use DI may be needed. This virtual identifier is recorded in the database rather than printed on each item. Identical items share it; it is not a different serial identifier for every piece. Do not apply the rule indiscriminately to IVD kits: check kit and component requirements separately.

Source:TGA: UDI for specific device types ；TGA: UDI and other device identifiers ；TGA: UDI requirements guidance

What goes into AusUDID, and who is responsible

AusUDID stores the UDI-DI and related device information, including model, manufacturer, packaging and Australian registration links. It does not collect personal patient information or actual production lot and serial values for every batch. Actual UDI-PI production values are not stored in AusUDID, so companies must retain this traceability information in their own production and supply records.

Both manufacturers and sponsors can submit UDI records, with different permissions. A manufacturer can publish device data but cannot add sponsor-specific ARTG links; the record is not publicly available until a sponsor links an ARTG entry. A sponsor can submit a complete record or link its ARTG entry to a manufacturer-published record. Regardless of who enters the data, the sponsor retains legal responsibility for Australian UDI compliance, record maintenance and accuracy.

Agree who supplies the device master data, reviews labels, submits records, links ARTG entries and handles change notifications and updates. Test fields and submission methods in the pre-production environment before using production. Continue maintaining records after supply rather than treating the first submission as completion.

Source:TGA: UDI and other device identifiers ；TGA: AusUDID roles and responsibilities ；TGA: UDI requirements guidance

Can an existing US or EU UDI be reused

TGA accepts eligible US or EU UDI carriers where the DI is issued by a recognised agency and the label also meets Australian regulatory and labelling requirements. Existing identifiers and packaging can reduce duplication, but one code does not automatically complete compliance in three markets. Check device versions, package quantities, label text, sponsor details and Australian database fields.

GUDID in the United States, EUDAMED in the EU and AusUDID in Australia are separate systems. An overseas database entry does not replace Australian submission or ARTG linking. Choose GS1, HIBCC or ICCBBA according to existing identifiers, device types and supply-chain systems; do not change identifiers solely for Australian entry without first assessing the need.

Source:TGA: Getting a UDI and using overseas labels ；TGA: AusUDID roles and responsibilities

What manufacturers can prepare now

Build a checkable list of every model and packaging configuration, then confirm applicable dates and submission arrangements with the sponsor before ordering large print runs. The following materials support product review and implementation planning:

• Device list: Australian classification, model, intended purpose, ARTG ID and current sponsor.
• Identifiers and packaging: issuing agency, existing DIs, packaging levels and quantities, artwork, instructions for use and applicable implant cards.
• Stock and dates: manufacture and labelling dates, batches, locations, supply status and evidence supporting any proposed transition.
• Overseas certificates: conformity assessment documents used for Australian supply, including extensions and transition status for legacy EU certificates.
• Quality system: responsible people and documented procedures for identifier allocation, artwork approval, submission and change notification.

If compliance may not be achieved by the applicable date, discuss the relevance and application requirements of Consent to Supply (CtS) with the sponsor promptly. CtS is not an automatic extension, and a pending application is not permission to continue supply. Sonictec can review the product classification, existing labels, ARTG and sponsor arrangements with you to discuss UDI preparation and ongoing Australian compliance.

Source:TGA: UDI compliance timeframes ；TGA: UDI requirements guidance

Further reading

• Australian UDI is being phased in: what should Chinese manufacturers check now?
• Why check UDI separately for a product already in the ARTG?
• Do existing EU or US UDI identifiers need replacing for Australia?