UDI FOR THE AUSTRALIAN MARKET
TGA AusUDID: prepare UDI data for Australia with confidence
A clear route from product identification to submission for manufacturers and Australian sponsors.
AusUDID is the Australian UDI database of the Therapeutic Goods Administration (TGA). It links device identifiers with product information. A database submission is separate from placing a UDI on the product and does not replace an applicable entry in the Australian Register of Therapeutic Goods (ARTG). TGA: purpose of AusUDID.
Europe IT Consulting supports data preparation, validation and UDI data transfer. The Global Submission Portal (GSP) supports structured Excel data; GUDI supports UDI data managed in SAP.
UDI on the label or device in accordance with the applicable requirements.
Identifiers, attributes and relationships for the AusUDID record.
Sponsor and ARTG relationship in the appropriate area of responsibility.
Which data belongs in AusUDID?
AusUDID records centre on the UDI-DI and product attributes, for example manufacturer, model, risk class, GMDN nomenclature, packaging and use information. Sponsor data supplements device data. AusUDID is not a patient record, inventory system or ongoing batch register.
UDI-DI and UDI-PI are different: the UDI-DI identifies the device model; the UDI-PI concerns production-related attributes. Individual serial or lot numbers are not submitted as a running stock record. TGA: UDI fundamentals.
Mandatory, conditional and optional fields must fit the specific device. Depending on the field, a change may require an update or a new identifier and record. TGA: data elements and change logic.
Which AusUDID deadlines matter?
The rollout follows device class. The first stage for Class III and IIb devices began on 1 July 2026. The dates below are core starting points, not a complete deadline calculation for every product.
Class III & IIb
First implementation stage
Class IIa
Further medical devices
Class Is · IVD 3 & 4
Sterile Class I and IVD
IVD 2 · covered IVD 1
Class 1 instruments / software
Do not derive a deadline from risk class alone. Exemptions, existing labelling, supply timing and direct-marking rules may matter. Use the TGA decision tree and TGA timeframe guidance for the concrete case.
Manufacturer, sponsor and service provider: who does what?
| Role | Responsibility in the data workflow |
|---|---|
| Manufacturer | Maintains device information. A manufacturer record alone does not establish a sponsor-specific ARTG relationship. |
| Australian sponsor | Remains responsible for AusUDID obligations and its corresponding ARTG relationship. |
| Europe IT | Provides the agreed preparation, validation and transfer process; technical support does not replace the sponsor’s regulatory responsibility. |
Four official AusUDID submission methods
| Method | What is transferred? | Key consideration |
|---|---|---|
| Online entry | Data entered in the AusUDID portal. | Consider effort and later maintenance. |
| Official Excel bulk upload | Records in the TGA workbook. | Up to 200 records per upload batch; this is not a general portfolio limit. |
| M2M with HL7 SPL | Structured XML messages under the TGA implementation. | Onboarding, permissions and testing are required. |
| GS1 NPC | Submission by the TGA-described GS1 National Product Catalogue route. | A separate route, not presented here as a Europe IT service. |
The right method depends on more than record volume. Frequency of change, data quality, packaging relationships, source system and approval workflow determine the practical effort.
From Excel or SAP: which Europe IT workflow fits?
Global Submission Portal
Prepare UDI data in the appropriate Excel template and upload it to GSP. The data is validated automatically. When there are no errors, the customer starts submission to the selected authority with “Transfer”.
GUDI in SAP
The customer manages UDI data in GUDI and transfers it directly from the GUDI process to the authority. Submission status and authority feedback can be retrieved and displayed; content corrections and resubmissions remain with the customer.
M2M requires approved access
For HL7 SPL, the TGA specifies registration, organisation credentials, pre-production testing and production activation. The customer organisation submits the required test confirmation itself. Europe IT implements the authority-specific steps agreed for the project and supplies onboarding guidance. TGA: HL7 SPL onboarding.
TGA AusUDID FAQ
Can existing EU or US UDI labels be used?
The TGA recognises GS1, HIBCC and ICCBBA. Existing labels may be reusable under Australian conditions, but a foreign database entry cannot simply be copied unchanged.
Is AusUDID the same as an ARTG registration?
No. AusUDID holds UDI-related product data. An applicable ARTG entry and its sponsor relationship remain separate responsibilities.
Are test records already a valid submission?
No. The pre-production environment is for testing; test data is not automatically moved to production.
What happens after the first transfer?
Status and feedback are reviewed. The customer corrects substantive data errors and initiates a resubmission where required. Product changes also need a governed maintenance process.
Put your AusUDID data on the right path
Tell us about the source system, device groups, sponsor/ARTG relationships and planned transfer frequency. Together we clarify how data preparation, validation and submission fit your workflow.
Editorial source check: 4 September 2026. The current TGA requirements govern the concrete regulatory use case.
