May 22, 2025

What You Need to Know About Australia’s Unique Device Identification (UDI) System in 2025

Australia’s medical device regulatory landscape continues to evolve, and 2025 has brought significant updates to the Unique Device Identification (UDI) system that manufacturers, developers, and regulatory professionals need to understand.

What Is UDI?

Unique Device Identification (UDI) is a globally harmonised system that assigns a unique code to each medical device. This code allows for improved traceability across the device lifecycle—from manufacturing through to distribution, use, and potential recall.

A complete UDI includes two main components:

  • UDI-DI (Device Identifier): A static identifier specific to the manufacturer and device model/version.
  • UDI-PI (Production Identifier): A dynamic component including details such as the device’s lot number, serial number, manufacturing date, or expiry date.

How the UDI System Works in Australia

Australia’s UDI framework is aligned with international approaches (such as those in the EU and US) but includes some specific local requirements:

  • UDI must be present on the device’s packaging and labelling, in both human-readable and machine-readable formats.
  • UDI data must be submitted to the Australian UDI Database (AusUDID) within 30 days of the device being supplied in Australia.
  • Compliance with the newly introduced Essential Principle 13C, which mandates UDI-related traceability documentation in the device’s technical file.

Key Updates in 2025

Class I Devices Excluded

Class I medical devices (non-sterile, non-measuring) are now excluded from mandatory UDI requirements. Despite this, manufacturers may still opt in to the system voluntarily to support consistency across global markets.

New Essential Principle 13C

Essential Principle 13C outlines comprehensive obligations related to UDI compliance, including:

  • Assigning UDI-DI and UDI-PI in accordance with regulatory expectations.
  • Understanding when a change (e.g., to sterility, material composition, software version) creates a new device “type” requiring a new UDI.
  • Submitting packaging version numbers and identifiers to the AusUDID.
  • Ensuring UDI data remains current and accurate.

This update reinforces the need for your Essential Principles Checklist to reference EP13C and demonstrate alignment with TGA regulations.

Direct Marking for Reusable Devices

Certain reusable medical devices must now have the UDI directly marked on the device itself in both machine-readable and human-readable formats, unless this would compromise safety or performance.

Exemptions apply to:

  • Implantable devices
  • Devices manufactured before their compliance date
  • Devices for which marking is impractical

Direct marking compliance deadlines:

  • Class III: 1 January 2028
  • Class IIb (non-implantables): 1 January 2029
  • Class IIa and Class Is: 1 January 2029
Voluntary UDI-DI Data Collection Program

The TGA has launched a voluntary submission program for UDI-DI data. This initiative allows manufacturers to:

  • Trial their data submission processes
  • Identify and resolve formatting or validation issues early
  • Familiarise themselves with AusUDID

Participating early can help reduce the risk of compliance delays closer to mandatory deadlines.

Upcoming Compliance Deadlines

Medical Devices
  • Class III and Class IIb (implantable): 1 July 2026
  • Class IIa: 1 July 2027
  • Class Is: 1 July 2028
  • Class I: Exempt from mandatory UDI requirements
In Vitro Diagnostic (IVD) Devices
  • Class 4 and Class 3: 1 July 2028
  • Class 2 and Class 1: 1 July 2029

Key Compliance Milestones

For each applicable device class, there are two major UDI compliance milestones:

  1. Labelling and Data Submission: Apply the UDI Carrier to device labels and packaging, and submit UDI records to the Australian UDI Database (AusUDID) within 30 days of the device being supplied in Australia.
  2. Direct Marking (for reusable devices): Apply the UDI directly on the device itself, where applicable.

Transition Arrangements

Devices manufactured and labelled before their respective compliance start dates (known as “existing devices”) are subject to specific transition arrangements. These devices may continue to be supplied without meeting UDI requirements, provided they are not relabeled or refurbished after the compliance date.

Additional Resources

More detail on the requirements and timeframes can be found at https://www.tga.gov.au/resources/guidance/complying-unique-device-identification-timeframes-medical-devices.