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Unique Device Identification (UDI) hub

Learn about Australia's Unique Device Identification (UDI) system and the Australian UDI Database (AusUDID).

The Australian Unique Device Identification (UDI) system supports accurate medical device identification and forms broader reforms to strengthen medical device regulation. 

UDI can:

  • improve the traceability of medical devices
  • support the management of safety-related activities
  • enable faster responses to recalls, safety alerts and adverse events.

Australia's UDI system aligns, where possible, with international approaches to  help improve the consistency and quality of device information while reducing regulatory complexity for industry.

The Australian UDI system is being implemented over 5 years, starting with higher-risk devices and progressively extending to lower-risk devices.

Understanding UDI

Learn the fundamentals of UDI, including how the Australian UDI system works, whether it applies to your devices, and your responsibilities.

Meeting UDI requirements

Understand how to comply with UDI requirements, including obtaining a UDI, applying UDI labelling, and meeting requirements for specific device types.

Accessing and using the AusUDID

Learn about the Australian UDI Database (AusUDID), including how to access the system, submit UDI records and manage data.

Maintaining compliance with UDI requirements

Understand your ongoing obligations for maintaining compliance with UDI requirements.

  • Managing UDI Triggers

    Learn which changes to a device are considered a UDI Trigger, and how to manage these changes.

  • UDI and Consent to Supply

    Learn about the streamlined Consent to Supply process for medical devices that do not meet Unique Device Identification (UDI)-related Essential Principles.

Resources and tools

Access guidance documents, templates, technical documentation and practical resources to support compliance with UDI requirements.

Engagement and events

Stay informed, participate in consultation activities, and access past engagement materials.

UDI for healthcare and consumers

Learn how UDI supports healthcare providers, healthcare organisations, patients and consumers.

  • UDI for healthcare

    Understand the benefits of UDI in healthcare and how healthcare organisations can prepare for and adopt UDI.

  • UDI for consumers

    Learn what Unique Device Identification (UDI) means for consumers and patients and how it can improve patient safety.

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