Australian UDI is being phased in: what should Chinese manufacturers check now?

Author:Sonictec · 2026-09-14 Updated

Identify the batch under discussion

Choose a product planned for near-term Australian supply and record intended use, Australian class, models, ARTG number or application status, and production/shipping plans. Explain differences within a model family. This grounds discussion in a real product and batch rather than whether the company generally needs UDI. These preparation suggestions do not replace applicability assessment.

Phased dates must be read together with scope

TGA's published timetable starts on 1 July 2026 for Class III and IIb; 1 July 2027 for Class IIa; 1 July 2028 for Class Is and Class 3 and 4 IVDs; and 1 July 2029 for in-scope Class 1 and 2 IVDs. Non-measuring, non-sterile Class I devices and Class Im devices are outside the mandatory scope, and not all Class 1 IVDs are included. Exemptions, existing-device provisions and transitions must be checked separately; these dates alone do not determine whether a batch may be supplied.

Source:TGA: Australian UDI overview ；TGA: UDI scope

Separate identifiers, labels and databases

Organise preparation into three areas: the product's identifiers; how they appear on actual labels and packaging; and who prepares and maintains Australian database information. A barcode image alone cannot demonstrate all three. Check label samples alongside data files; if names, models or pack quantities differ, establish which version matches the product intended for Australia.

Do not assess stock using the ARTG inclusion date

Registration, manufacturing, labelling and supply dates are different. New batches of an existing model still need assessment. For existing-device or transitional provisions, obtain verifiable batch information from production, quality and Australian partners and check current guidance. Years of prior sales alone do not establish eligibility.

Source:TGA: UDI implementation dates and transitions

Give the manufacturer and Sponsor a workable handover plan

Agree who holds the final model and packaging list, supplies label samples, checks data, submits and retains results, and notifies changes. Manufacturers and Sponsors have applicable UDI responsibilities that external assistance does not remove. A gap list and responsibility plan may be a useful first output without purchasing a complex system.

Source:TGA: manufacturer and Sponsor UDI responsibilities

Preparation you can start now

Summarise one product's use and class, ARTG status, existing UDI, label and packaging samples, manufacturing/labelling dates and Australian supply plans. Assign owners for missing information, then assess label changes, data completion or transitions. Do not post technical files or client information in public comments.

Discuss further

To discuss Australian preparation, describe your product, ARTG status and supply plans to Sonictec. Specific UDI tasks depend on documents and the scope we can undertake. This article explains preparation methods and makes no product-specific compliance, price or completion-time promise.

Further reading

• Why check UDI separately for a product already in the ARTG?
• Do existing EU or US UDI identifiers need replacing for Australia?
• What should you prepare before a TGA registration consultation?