Author:Sonictec · Updated
Check the source of existing identifiers
TGA accepts UDI carriers compliant with EU or US requirements subject to conditions, including a UDI-DI from a recognised issuing agency and labels meeting current Australian regulatory requirements. Begin by checking the issuing agency and identifier records, rather than simply looking for a QR code or barcode on the packaging.
Source:TGA: obtaining UDI and using overseas UDI
Check actual Australian models and packaging
Start with a specific model and collect samples and identifier records for the unit and each packaging level, marking the Australian version. If global and Australian ranges differ, separate models not supplied to Australia to avoid transferring the entire global catalogue into Australian records.
Reusable evidence must meet conditions; a promise is not evidence
For an initial review, group documents as available and matching, available but needing verification, or not yet prepared. Review and reuse existing material before redoing work. Explain any differences and their impact before deciding how to address them. This is an organisational suggestion, not an official TGA classification.
Verify overseas and Australian databases separately
AusUDID holds Australian device identifiers and related product information, linked to the relevant ARTG inclusion. Confirm who will prepare the Australian data, check product matching and maintain updates. An overseas database entry does not establish that the Australian record exists or is consistent.
Source:TGA: Australian UDI overview
Data handover needs a defined version
Have label and data owners check the same product materials and record versions, dates and unresolved differences. If departments maintain different model lists, confirm which matches current Australian products before progressing. Do not defer discrepancies until submission.
A hypothetical example
Suppose a company has European packaging but will initially supply only two models in Australia. Check those models' labels and identifier records, Australian requirements and data responsibilities. Neither stop checking because European barcodes exist nor recode the entire range. This illustrates sequencing, not a conclusion that a particular product can reuse its identifiers.
If you would like to discuss this with Sonictec
Start with the product, issuing agency, current identifiers and labels, ARTG status, and whether you need help with applicability, document coordination or responsibilities. Support and deliverables are confirmed after reviewing the information.
Frequently asked questions
Must existing overseas UDI identifiers always be replaced?
Not necessarily. EU or US UDI carriers meeting the conditions may be accepted, but the issuing agency, Australian label requirements and data arrangements still need checking.
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?
- How do TGA registration consulting and an Australian Sponsor differ?
Official references
- TGA: obtaining UDI and using overseas UDI
- TGA: Australian UDI overview
- TGA: manufacturer and Sponsor UDI responsibilities
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.