The Australian Therapeutic Goods Administration (TGA) is implementing Unique Device Identification (UDI) requirements for medical devices supplied in Australia. These requirements are aligned with global UDI frameworks used by regulators such as the FDA and the European Union, and are intended to improve device traceability, post-market safety monitoring, and recall management.
Key Deadline – 1 July 2026
Manufacturers of the following devices must comply with UDI requirements by: 1 July 2026
This applies to:
- Class III medical devices
- Class IIb medical devices
- Certain implantable devices
These devices are the first group required to comply, with lower risk devices following in later phases of the TGA implementation timeline.
What Compliance Requires
To meet the UDI requirements, manufacturers must implement two key elements.
1. UDI on Device Labels and Packaging
Each applicable device must have a Unique Device Identifier (UDI) applied to:
- Device labels
- All relevant packaging levels
The UDI must be presented in both:
- Human-readable format, and
- Machine-readable format (e.g. barcode).
A UDI consists of:
- UDI-DI (Device Identifier) – identifies the device model
- UDI-PI (Production Identifier) – identifies production data such as batch or lot number.
2. Upload of UDI Data to the Australian UDI Database (AusUDID)
Manufacturers (or sponsors acting on their behalf) must upload device identification data to the Australian UDI Database (AusUDID).
The AusUDID stores:
- UDI-DI information
- Device identification data
- Linkage to the relevant ARTG entry (critical task performed only by Sponsor)
Recommended Preparation Steps
As most manufacturers already comply with EU or FDA UDI requirements, many core elements of UDI implementation are likely in place. Preparation for the Australian requirements will therefore primarily involve aligning existing UDI information with the Australian system and submitting the required data to the TGA.
Manufacturers of Class IIb and Class III devices should focus on the following actions:
- Confirm existing UDI identifiers
Verify that UDIs issued through a recognised issuing agency (e.g. GS1 or HIBCC) are available for all devices supplied in Australia. - Confirm Australian label compliance
Ensure device labels and packaging supplied in Australia include the UDI in both human-readable and machine-readable format, consistent with Australian requirements.
- Prepare device data for AusUDID submission
Compile the required UDI-DI device information and attributes that must be uploaded to the Australian UDI Database.
- Align UDI data with ARTG entries
Ensure the device identifiers being submitted correspond correctly to the respective devices listed under your ARTG inclusion(s).
- Plan AusUDID submission
Determine the approach for submitting UDI information to the AusUDID (either directly by the manufacturer or leveraging the Australian sponsor to manage the entire process seamlessly, including the required linkage to the relevant ARTG entry).
How MDSS AU Can Support You
As your Australian Sponsor, MDSS AU can support manufacturers with UDI compliance activities, including:
- Support with UDI strategy and implementation
- Assistance with preparing UDI data for submission
- Uploading and maintaining device information in the AusUDID
- Ensuring alignment between UDI data and ARTG entries
Next Steps
If your devices fall within Class IIb or Class III, we recommend beginning your UDI preparation activities now to ensure compliance by 1 July 2026.
If you would like to arrange a discussion on how MDSS AU can assist with UDI implementation or AusUDID submissions, please contact us at info@mdssar.com.
MDSS will be hosting a webinar dedicated to Preparing for TGA UDI Requirements: What to Expect and What to Do Next (Including EUDAMED & Swissdamed Updates). We highly recommend that you register here and attend to gain valuable insights.
