The Therapeutic Goods Administration (TGA) has published Version 2.1 of “Complying with the Unique Device Identification timeframes for medical devices — Timeframes for supplying UDI compliant medical devices in Australia”. The document sets out the implementation timeframes for Unique Device Identification (UDI) in Australia, transition arrangements for existing devices, specific transition periods for EU MDD and IVDD devices, and the principal responsibilities of manufacturers and Australian registration holders (Sponsors).
Source: TGA — New UDI requirements for medical devices commence 1 July 2026 | www.tga.gov.au/news/news-articles/new-udi-requirements-medical-devices-commence-1-july-2026
1. UDI Implementation Timeframes — Medical Devices (MD)
| MD Class | UDI Labelling and AusUDID Data Submission | Direct Marking |
| Class III | 1 July 2026 | 1 January 2028 |
| Class IIb | 1 July 2026 | 1 January 2029 * |
| Class IIa | 1 July 2027 | 1 January 2029 |
| Class Is | 1 July 2028 | 1 January 2029 |
| NOTESDirect Marking — Direct marking of the device itself.Australian UDI Database — AusUDID.* Direct marking requirements do not apply to implantable Class IIb devices. |
2. UDI Implementation Timeframes — In Vitro Diagnostic Devices (IVD)
| IVD Class | UDI Labelling and AusUDID Data Submission | Direct Marking |
| Class 4 | 1 July 2028 | 1 July 2029 |
| Class 3 | 1 July 2028 | 1 July 2029 |
| Class 2 | 1 July 2029 | 1 July 2030 |
| Class 1 | 1 July 2029 | 1 July 2030 |
| NOTEWhere the product itself is not a device that requires direct marking, for example a single-use IVD, the direct marking requirement does not apply. |
3. Transition Arrangements for Existing Devices
Existing devices are those that have already been manufactured and labelled before the corresponding mandatory UDI compliance date for that class.
| Product Situation | Transition Arrangement |
| Existing Class III and Class IIb devices still under the control of the Sponsor | Must be relabelled before 1 July 2029 to meet the UDI requirements. |
| Class III and Class IIb devices already supplied and no longer under Sponsor control | The product may continue to benefit from the transition arrangements throughout its lifecycle. |
| Existing Class IIa and Class Is devices | Relabelling permitted within the device lifecycle. |
| Existing IVD devices | Relabelling permitted within the device lifecycle. |
| All qualifying existing devices | Exempt from the direct marking requirements within the device lifecycle. |
| NOTESponsor Control — a product has left the manufacturer but remains under the actual control of the Sponsor and has not yet been fully supplied. |
4. Special UDI Transition Period for EU MDD Devices
For products that satisfy the applicable conditions and remain in the transition period from EU MDD to EU MDR, the TGA has put in place additional UDI transition arrangements.
| MD Class | UDI Labelling and AusUDID Submission | Direct Marking |
| Class III | 1 January 2028 | 1 January 2028 |
| Class IIb (implantable) | 1 January 2028 | Not applicable |
| Class IIb (non-implantable) | 1 January 2029 | 1 January 2029 |
| Class IIa | 1 January 2029 | 1 January 2029 |
| Class Is | 1 January 2029 | 1 January 2029 |
Where a product completes its transition to EU MDR before the end of the above transition period, the corresponding MDD transition arrangements cease to apply.
5. Special UDI Transition Period for EU IVDD Devices
For products that satisfy the applicable conditions and remain in the transition period from EU IVDD to EU IVDR, the TGA has put in place additional UDI transition arrangements.
| IVD Class | UDI Labelling and AusUDID Submission | Direct Marking |
| Class 4 | 1 July 2028 | 1 July 2029 |
| Class 3 | 1 January 2029 | 1 January 2029 |
| Class 2 | 1 January 2030 | 1 July 2030 |
| Class 1 | 1 January 2030 | 1 July 2030 |
Where a product completes its transition to EU IVDR before the end of the above transition period, the corresponding IVDD transition arrangements cease to apply.
6. Principal Responsibilities of Manufacturers and Sponsors
| Responsible Party | Principal Duties |
| Manufacturer | Responsible for the allocation of UDI codes, including UDI-DI and UDI-PI. Update product labels and applicable packaging. Complete direct marking where applicable. Implantable devices must additionally reflect the UDI on the Patient Implant Card. |
| Australian registration holder (Sponsor) | Responsible for submitting UDI records to AusUDID and for linking them to the corresponding ARTG (Australian Register of Therapeutic Goods) entries, ensuring data accuracy and continued update. UDI records must in principle be submitted within 30 days of the product being supplied in Australia. |
7. Consequences of Failure to Comply on Time
Where a product cannot satisfy the UDI requirements before the mandatory implementation date, the Sponsor may apply in advance for a CtS (Consent to Supply). Products that do not comply should not continue to be supplied before TGA approval is obtained.
Where UDI compliance is not completed as required, the TGA may take regulatory action, including the suspension or cancellation of ARTG entries, civil penalties and the issuing of infringement notices.