In this article
What UDI is designed to doThe phased Australian timetableUDI is not the ARTG numberWhat consumers may see on packagingExample: putting the information in contextWhat to check nextFrequently asked questionsWas UDI compulsory for every device on 1 July 2026?Can UDI replace checking ARTG status?Read more on this topicOfficial sourcesRelated articles
Unique Device Identification (UDI) is a traceability system for certain medical devices. Australia began mandatory UDI compliance on 1 July 2026 for Class III and Class IIb devices, with other covered classes following a phased schedule.
What UDI is designed to do
UDI helps users and healthcare systems identify specific kinds of devices and, where applicable, production identifiers. It supports traceability, recordkeeping, safer recalls and more reliable links to device information.
The phased Australian timetable
TGA guidance states mandatory UDI requirements begin for Class III and IIb medical devices on 1 July 2026, Class IIa on 1 July 2027 and further in-scope categories later. Some devices and situations have exemptions or transition arrangements. Not all Class I medical devices fall within the same rules.
UDI is not the ARTG number
An ARTG number identifies a register entry. A UDI combines device-identification elements, potentially with production details, under a different system. A barcode or UDI alone does not establish whether a given use of a product is authorised.
What consumers may see on packaging
A compliant device may display a machine-readable UDI carrier and human-readable information. The Australian UDI Database (AusUDID) supports access to device details. Its data and applicability must be interpreted in line with the product’s class and implementation date.
Example: putting the information in context
A hospital scans a labelled device to record its precise identifier. That scan may help trace a safety communication later, but the clinician still needs the current instructions and a valid regulatory basis for using the device.
What to check next
- Check the device’s class and relevant mandatory UDI date.
- Differentiate a UDI identifier from an ARTG number and serial number.
- Use AusUDID guidance without assuming every device is already in scope.
Frequently asked questions
Was UDI compulsory for every device on 1 July 2026?
No. Mandatory requirements are phased by class and particular transitional rules.
Can UDI replace checking ARTG status?
No. They answer different identification questions.
Read more on this topic
- Medical Devices & TGA: topic overview
- How to Read Medical Device Product Documentation
- How Accessories Can Be Regulated as Medical Devices
Official sources
- TGA — Unique Device Identification implementation in Australia
- TGA — Searching the Australian Register of Therapeutic Goods
This educational information is not individual medical advice. It does not establish the regulatory status or suitability of an unidentified device, and must not be read as authorisation to advertise vaping goods to the Australian public.