Getting Started with Unique Device Identification (UDI) for Medical Devices in Australia

1. Introduction and Purpose

The Therapeutic Goods Administration (TGA) provides the 'Getting Started with UDI' page to offer a high-level overview for sponsors and manufacturers of medical devices. It helps determine if UDI applies to specific devices, outlines compliance preparation steps, and explains interaction with the Australian UDI Database (AusUDID). This supports Australia's introduction of Unique Device Identification to enhance patient safety, traceability, post-market surveillance, and alignment with global standards. TGA Getting Started with UDI (last updated 22 September 2025)

The page was originally published on 16 July 2025 and updated with additional videos, introductory text, an updated retail reference guide, and information on AusUDID user roles. TGA Getting Started with UDI

2. Determining Applicability of UDI

To check if UDI requirements apply and when compliance is required, use the provided resources:

• UDI Flowcharts:
  • Does UDI apply to my device? (PDF)
  • When does UDI apply to my device? (PDF)
• Interactive Decision Trees:
  • Does UDI apply to my device
  • When does UDI apply to my device

These tools guide users through device classification, supply status, and transitional arrangements (e.g., for devices under EU MDD certificates). TGA Getting Started with UDI

3. Key Compliance Timelines (as of 2026)

Regulations took effect and AusUDID became live on 24 March 2025. Mandatory phased compliance begins:

• 1 July 2026 for Class III and Class IIb medical devices (labelling and data submission to AusUDID).
• Higher-risk devices prioritized first, with lower classes following in subsequent years up to 30 June 2030 for full implementation across all applicable devices.
• Voluntary compliance (labelling and data submission) is allowed and encouraged before mandatory dates. TGA Complying with UDI Timeframes

For certain reusable devices, Direct Marking requirements apply later (e.g., from 1 January 2028 for some classes). Transitional provisions exist for legacy devices manufactured before key dates. TGA Getting Started with UDI

4. Preparation Checklist and Resources

A detailed Preparing for UDI and AusUDID checklist covers:

• Understanding requirements
• Preparing systems and data
• Testing UDI record submission

Access: Preparing for UDI and AusUDID checklist. TGA Getting Started with UDI

Educational videos explain basics:

• What is a UDI
• UDI overview (global context)
• Australian UDI framework
• UDI packaging levels
• UDI Triggers
• Direct Marking
• Unit of Use

Quick Reference Guides provide concise overviews:

• UDI for medical devices
• UDI for in vitro diagnostic devices
• UDI for retail devices

TGA Getting Started with UDI

5. Australian UDI Database (AusUDID) Basics

AusUDID is the central repository for UDI data submission and maintenance. Resources include:

• Welcome to AusUDID (PDF) – covers environments (Production/Pre-Production), user types, submission methods
• Logging into AusUDID environments (PDF)
• AusUDID user roles (PDF, updated September 2025) – explains how organisation type and TGA Business Services roles affect access
• Guides on adding/editing UDI records (online portal or bulk upload using Australian UDI Bulk Upload Template)
• Key concepts for adding and editing records

TGA Getting Started with UDI

6. Additional Guidance and Related Links

For detailed compliance:

• Complying with the Unique Device Identification requirements for medical devices
• Complying with the Unique Device Identification timeframes for medical devices
• The Australian UDI Database for sponsors and manufacturers
• UDI resources and technical documents

TGA Getting Started with UDI

Sponsors and manufacturers should begin preparation early, especially for higher-risk devices approaching the 1 July 2026 milestone, to ensure smooth transition and avoid compliance issues. Voluntary early adoption reduces risks and supports better traceability in healthcare settings.