Overview of Unique Device Identification (UDI) in Australia

1. Introduction and Purpose

Unique Device Identification (UDI) is a system that assigns a unique code to medical devices throughout their distribution and use. In Australia, UDI aims to:

• Enhance the ability to identify medical devices
• Improve traceability throughout the supply chain
• Facilitate targeted field safety corrective actions
• Support better post-market surveillance and adverse event reporting
• Align Australia with international standards for global harmonisation

The TGA adopted UDI following recommendations from the International Medical Device Regulators Forum (IMDRF) and in line with major jurisdictions such as the US FDA, EU, and others. TGA About UDI in Australia (last updated 22 September 2025)

2. Components of a UDI

A UDI comprises two parts:

• Device Identifier (DI): A fixed portion that identifies the labeler and the specific version or model of a device (e.g., catalogue number, version, packaging level).
• Production Identifier (PI): Variable data that may include lot/batch number, serial number, manufacturing/expiration date, or donation identification number (for HCT/Ps).

UDI must be presented in both human-readable (plain text) and machine-readable (e.g., barcode, RFID) formats on the label and/or packaging. TGA About UDI in Australia

3. Australian UDI Database (AusUDID)

The AusUDID is the TGA’s publicly accessible database for UDI information. Key features:

• Sponsors (Australian legal entities responsible for the device) submit and maintain UDI records.
• Data includes DI, device description, GMDN code, risk classification, and other core data elements per IMDRF guidance.
• Public access allows healthcare providers, regulators, and patients to look up device information.
• Submission methods: online portal or bulk upload.

AusUDID became operational on 24 March 2025. TGA About UDI in Australia

4. Issuing Agencies and Standards

TGA recognises three accredited issuing agencies:

• GS1 (most widely used globally)
• HIBCC (Health Industry Business Communications Council)
• ICCBBA (for blood, tissues, and cellular therapy products)

UDI formats must comply with standards issued by these agencies and align with IMDRF UDI guidance. TGA About UDI in Australia

5. Mandatory Implementation Timelines

UDI requirements are being rolled out in phases based on device risk classification:

• Higher-risk devices (Class III and implantable Class IIb): mandatory labelling and AusUDID submission from 1 July 2026.
• Subsequent phases for Class IIb (non-implantable), Class IIa, Class I sterile/measuring, and Class I devices follow in later years, with full mandatory compliance targeted by 30 June 2030.
• Direct marking (permanent marking on reusable devices) has later start dates for certain classes.
• Transitional arrangements apply for legacy devices and those under EU MDD certificates.

Voluntary compliance has been permitted since AusUDID launch. TGA About UDI in Australia

6. Labelling and Direct Marking Requirements

• UDI must appear on the label and higher-level packaging (where applicable).
• For reusable devices requiring cleaning/sterilisation, direct marking (permanent UDI on the device itself) is required for certain classes, with phased implementation.
• Exemptions and special cases exist (e.g., custom-made devices, investigational use). TGA About UDI in Australia

7. Benefits and Global Alignment

Implementing UDI supports:

• Faster and more accurate identification during adverse events
• Efficient recalls and field safety actions
• Reduced medical errors
• Improved inventory management in healthcare facilities

Australia’s framework is harmonised with IMDRF UDI guidance and compatible with major markets (US, EU, etc.), facilitating international supply chain efficiency. TGA About UDI in Australia

For detailed requirements, timelines, and technical specifications, refer to the TGA’s UDI hub and related guidance documents. Sponsors are encouraged to prepare early, especially for devices in the first mandatory phases starting 1 July 2026.