UDI requirements

We have amended the Essential Principles in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 - external site to set out the requirements for Unique Device Identification (UDI).

This includes:

• requirements for obtaining the UDI-Device Identifier (UDI-DI) from a Therapeutic Goods Administration (TGA) recognised Issuing Agency
• requirements for formatting the UDI-Production Identifier (UDI-PI) per Issuing Agency requirements
• requirements for obtaining a new UDI-DI due to changes to the medical device that make the medical device a new model (UDI Trigger)
• requirements for applicable packaging of a medical device (if any) to be labelled with a Package DI
• requirements for UDI on Patient Implant Cards (PICs) per Essential Principle 13A
• requirements for the direct marking of a medical device with a UDI, where applicable
• requirements for the submission of UDI-DI(s) and related mandatory data in the AusUDID, including timing of submission of data
• mandatory compliance dates, including transition periods.

For detailed information on UDI requirements, see Complying with the Unique Device Identification requirements for medical devices.

As the UDI requirements form part of the Essential Principles, we may take regulatory action if you are non-compliant, 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.

You can learn more on our Compliance actions and outcomes page.

Unique Device Identifier (UDI)

A UDI is made up of 2 parts: 

• UDI Device Identifier (UDI-DI)
• UDI Production Identifier (UDI-PI). 

To be compliant with Australian UDI requirements, you must get your UDI-DI from one of our TGA recognised Issuing Agencies. Your UDI must conform with the rules of the Issuing Agency you choose.

The UDI-DI is the unique numeric or alphanumeric code that identifies the model of medical device. 

The UDI-DI is the ‘access key’ to information stored in the AusUDID. It is used when reporting medical device related regulatory events such as adverse events and recalls. It is used to distinguish a model of medical device and find up-to-date information about the device in the AusUDID. In the AusUDID, the UDI-DI is referred to as the ‘Primary DI’.

Examples of identifiers from an Issuing Agency that can be a UDI-DI include:

• GS1 Global Trade Item Number (GTIN)
• Health Industry Bar Code – Universal Product Number (HIBC-UPN)
• International Council for Commonality in Blood Banking Automation Information Standard for Blood and Transplant 128 - Processor Product Identification code (ICCBBA ISBT 128-PPIC).

Each model of medical device must have a unique UDI-DI. If you supply multiple models of medical devices under a single ARTG inclusion, you must allocate a different UDI-DI to each model, and link all models supplied under the ARTG entry to the ARTG ID. 

The UDI-PI identifies the production specific information such as the batch, lot, software version or manufacturing date of the medical device’s production run. 

The UDI-PI is present on the medical device itself or the medical device base package but is not stored in the AusUDID. The UDI-PI supports device related reporting of regulatory events such as adverse events and recalls.

Devices required to meet UDI requirements

Medical devices and IVDs that you supply in Australia that must be included in the ARTG must comply with UDI requirements, unless otherwise exempt from these requirements. 

To comply with UDI requirements, you must meet all your obligations. If applicable, you must also:

• meet any extra requirements, such as Unit of Use or Direct Marking
• meet any device specific requirements
• meet all further requirements as stipulated in the Regulations.

The following table describes which medical device classes must meet UDI requirements. These devices must meet all UDI requirements, unless specifically exempt.

The following table describes which IVD classes must meet UDI requirements. These devices must meet all UDI requirements, unless specifically exempt.

Devices exempt from UDI requirements

You are not required to meet UDI requirements for:

• medical devices that are Class I non measuring nonsterile 

• medical devices that are Class I measuring (Im)

• in house IVDs

• custom-made medical devices

• patient-matched medical devices with a volume of 5 or less supplied each financial year

• medical devices exempt under Special Access Scheme (SAS) or Authorised Prescriber (AP) Scheme

• Surgical Loan Kits (SLKs) at kit level.

While these devices are exempt from complying with UDI requirements, you may choose to meet UDI requirements for these devices. 

Getting a UDI

As a manufacturer, you must apply and get a UDI-DI from one of our recognised Issuing Agencies. This is to ensure that the UDI is globally unique and complies with global standards. 

It is the responsibility of the manufacturer to choose an Issuing Agency. As a sponsor, it is your responsibility to liaise with your manufacturer if you have a preferred Issuing Agency. 

We recognise the following UDI Issuing Agencies: