By Dr Roy Hardman
Over the past few years, the Unique Device Identification (UDI) has been discussed, sort community engagement and the legislative process placed into action.
The first phase of the UDI introduction is to take place on the 1st of July 2026: are you ready?
What is a UDI?
The Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 was registered on 24 March 2025, enacting Australia’s UDI regulatory framework. This new legislation will implement UDI compliance for medical devices to enhance traceability, with mandatory requirements for medium to high-risk (Class IIb and III) devices beginning 1 July 2026.
(https://www.tga.gov.au/resources/legislation/therapeutic-goods-legislation-amendment-australian-unique-device-identification-database-and-other-measures-regulations-2025 )
What are the key aspects of this amendment?
Framework Activation: The amendments officially establish the regulatory framework, allowing the Therapeutic Goods Administration (TGA) to implement mandatory UDI labelling and data submission.
Phased Compliance: While some provisions are active, mandatory compliance follows a phased approach, starting with high-risk and implanted devices in 2026.
AusUDID Implementation: The Australian UDI Database (AusUDID) is now the official central repository for UDI-DI and related data, managed by the TGA.
Labelling Requirements: The legislation mandates that devices bear a UDI carrier, with some requirements for direct marking on specific, reusable devices. (the respective bar code)
Key dates & action items:
24 March 2025: Regulations registered; voluntary compliance and voluntary submission to Aus UDID began.
1 July 2026: Mandatory UDI compliance starts for Class III and Class IIb (implantable) medical devices.
Post-2026: Further phased deadlines for lower-risk device classes will be enacted. (Framework Activation: The amendments officially establish the regulatory framework, allowing the Therapeutic Goods Administration (TGA) to implement mandatory UDI labelling and data submission.
Getting started
If you are looking for some key starting points please refer to the below links
https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub/getting-started-udi
https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub
To prepare a Unique Device Identifier (UDI) in Australia, you must obtain a UDI-Device Identifier (UDI-DI) from a TGA-recognised Issuing Agency, label the device packaging and directly mark reusable devices with the UDI-DI and UDI-Production Identifier (UDI-PI), and submit this information and related device data to the Australian UDI Database (AusUDID). This involves applying the human-readable and machine-readable UDI carrier (like a barcode) to all applicable packaging levels and implantable devices.
Key steps for UDI preparation
Obtain a UDI-Device Identifier (UDI-DI):
Apply to a TGA-recognized Issuing Agency (e.g., GS1, Health Product Declarations) to get a globally unique UDI-DI for each device model.
Create the UDI-Production Identifier (UDI-PI):
This identifier contains production-specific information such as lot/batch number, serial number, and expiry date.
Apply UDIs to devices and packaging:
Packaging: Apply the UDI Carrier to all applicable levels of packaging, ensuring both human-readable and machine-readable formats.
Direct marking: For reusable medical devices, directly mark the UDI onto the device itself.
Patient Implant Cards (PICs): Include the UDI on PICs for implantable devices along with the device name, model, and batch/serial number.
Submit UDI information to AusUDID:
Log in to the Australian UDI Database (AusUDID) and submit the UDI-DI, related mandatory data (like device class, manufacturer details, and GMDN code), and links to the Australian Register of Therapeutic Goods (ARTG) ID.
Link to other administrative tasks:
Include the UDI on all relevant notifications to the TGA, such as adverse event reports, incident reports, recalls, and corrections.
Many overseas manufacturers have been working on this for some time and have taken up the opportunity to download the TGA spreadsheets to be able to upload bulk device UDI’s. (also available form the TGA websites.
Time frames to keep in mind
Mandatory UDI Compliance Timeframes (Labelling & Data Submission)
1 July 2026: Class III (high-risk) and Class IIb (implantable) medical devices.
1 July 2027: Class IIa (medium-risk) medical devices.
1 July 2028: Class 4 (highest risk) IVD medical devices.
1 July 2029: Class 1 (low-risk) medical devices and Class 1, 2, and 3 IVD medical
If you have not already done so, contact your manufacturers and suppliers to assess whare they are within these time frames so as not to void these time frames.
Remember it is also mandatory for any company the has registered devices under MDSAP to also comply with these UDI regulations.
For further assistance with this or any other TGA requirement please contact Dr Roy J Hardman Specialist TGA Medical Devices consultant on +61 419100978 or roy@righttimebusiness.com.au
