Author:Sonictec · Updated
Separate registration records from implementation records
An ARTG number is a starting point for checking Australian product registration, but does not replace label samples, identifiers or data preparation records for the current batch. Keep two sets of records: registration and product scope, and the labels and data used for the actual supply batch. Both should identify the same product so the manufacturer and Sponsor can check them together.
An old model and an existing device are different assessments
For existing-device or transitional arrangements, check manufacturing, labelling, controls and supply conditions against current TGA timing guidance. An earlier ARTG inclusion date does not prove every batch in storage qualifies. List batches separately, especially returns, resupply or different packaging versions, before assessing them.
Source:TGA: UDI implementation dates and transitions
A UDI label update should not automatically be treated as re-registration
TGA states that label or material changes made solely to meet UDI requirements do not, by themselves, require a device to be re-registered or re-certified. If intended use, models or other product information also change, do not group everything as a UDI label change. Separate the changes and assess the applicable processes.
Source:TGA: UDI and other regulatory processes ；TGA: varying ARTG entries for medical devices and IVDs
Records should show who did what
Keep final label versions, model-to-identifier mappings, data checks and handover confirmations. If someone already submits data, define who receives exceptions, approves corrections and triggers updates. Records should let new team members understand the status without relying on one person's chat history.
Four initial questions for stock on hand
When was this batch manufactured and labelled? Who controls it and how will it be supplied? Which labels and packaging does it use? Where are the classification, rules and evidence supporting the assessment? This is an organisational sequence, not an automatic exemption test. Record uncertainty for verification rather than skipping it because stock is already in Australia.
If you only need to know whether immediate rework is necessary
Do not immediately replace all packaging, or continue supply based only on ARTG inclusion. Select an actual batch, gather the information above and check conditions with responsible parties. Different batches may need different treatment; one blanket conclusion can cause unnecessary rework.
Starting a discussion with Sonictec
Provide the ARTG number, class, batch and labelling status, and the supply issue of greatest concern. Additional specialist support can be defined after review. An ARTG number alone is not a UDI compliance conclusion.
Frequently asked questions
Can we skip UDI checks if we already have ARTG inclusion?
You still need to check UDI scope, applicable dates and the actual batch arrangements. The inclusion date does not replace manufacturing, labelling and supply information.
Further reading
- Australian UDI is being phased in: what should Chinese manufacturers check now?
- Do existing EU or US UDI identifiers need replacing for Australia?
- When should you contact your Australian Sponsor about post-registration changes?
Official references
- TGA: UDI implementation dates and transitions
- TGA: UDI and other regulatory processes
- TGA: varying ARTG entries for medical devices and IVDs
Sources checked: 2026-09-14. Assess individual products and projects against current applicable requirements.