Introduction to UDI requirements

The Australian Government introduced the Australian UDI system to strengthen patient safety and improve medical device traceability. This system is part of broader medical device reforms outlined in An Action Plan for Medical Devices.

The UDI system supports the identification of medical devices and other medical device reforms. It is designed to improve the effectiveness of the regulatory framework, including management of post-market safety-related activities such as recalls.

The inability to effectively and efficiently track and trace medical devices that have been supplied to or implanted into patients has constrained timely clinical and regulatory action in a number of medical device safety crises. This includes hip implants, urogynaecological mesh and breast implants.

When adopted across the supply chain, clinical and other health systems, UDI can enable easier and faster identification of medical devices. This supports:

• removal of those medical devices from storage and distribution to prevent further use
• faster identification of medical devices implanted into patients in the event of an adverse event, safety advisory or recall.

The Australian UDI Database (AusUDID) gives patients, consumers and health professionals consistent, easy access to information about the medical devices they use.

By introducing UDI, Australia joins a globally harmonised approach that enables more accurate identification of medical devices.

Please note that the Australian UDI system and the AusUDID are not designed to track inventory information for medical devices, such as stock levels. While UDI can support supply chain processes, this is only a secondary benefit, not the primary purpose of UDI regulations in Australia.

UDI requirements do not replace or override any existing requirements or obligations of sponsors or manufacturers of medical devices supplied in Australia.

UDI requirements apply in addition to existing regulatory requirements.

UDI overview

Australian UDI framework

Global alignment

We have aligned the Australian UDI requirements with global UDI requirements where possible. This includes: 

• accepting UDI Carriers compliant with European Union (EU) and United States (US) regulations
• aligning with the International Medical Device Regulators Forum (IMDRF) UDI Guidance IMDRF/UDI WG/N7FINAL:2013 and IMDRF UDI System Application Guide.
• recognising internationally accepted Issuing Agencies
• minimising Australian only requirements, whilst maintaining robust regulation.

UDI in the Essential Principles

The Essential Principles (EPs) in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 include the UDI requirements.

The table below shows each Essential Principle that relates to UDI and where in this guidance you can find details on the requirements.

Non-compliance

As UDI requirements form part of the Essential Principles, we may take regulatory action if you do not comply, including:

• suspension or cancellation of your devices from the Australian Register of Therapeutic Goods (ARTG)
• applying civil penalties as outlined in Part 4-11, Division 1 of the Act
• issuing infringement notices.

See the TGA website for compliance actions and outcomes.

Consent to Supply (CTS) for noncompliant medical devices

If you cannot meet UDI requirements by the UDI compliance date, you may choose to submit an application for consent to supply.

You must lodge the application well in advance of the UDI compliance date with supporting documentation. We must consider and decide on the application before you supply the non-compliant device.

Please note that a CTS application is considered by the delegate on a case-by-case basis and granted in exceptional circumstances for limited periods of time.

Where we grant CTS for a device, your ongoing regulatory responsibilities remain. These responsibilities include the requirement to undertake recalls, other market actions and reporting of adverse events. You can learn more on our website about your post-market responsibilities for medical devices.

Preparing for UDI checklist

For those new to UDI, we recommend reviewing the Preparing for UDI and AusUDID checklist.

This checklist outlines key considerations for sponsors and manufacturers preparing to comply with Australia’s UDI requirements.

It includes suggested timeframes, related resources, and roles that may be involved in each activity.

UDI decision trees

We have developed 2 decision trees to help sponsors and manufacturers determine whether UDI requirements apply to their devices, and if so, when:

• Does UDI apply to my device
• When does UDI apply to my device