Australian UDI Database

The Australian UDI Database is now live.

Sponsors and manufacturers can access AusUDID Production here: TGA eBusiness Services

Healthcare and consumers can access AusUDID Production here: TGA AusUDID

The Australian Unique Device Identification Database (AusUDID) stores unique device identifiers and related data for medical devices supplied in Australia. The data in the AusUDID also links to the relevant inclusion(s) in the Australian Register of Therapeutic Goods (ARTG).

Sponsors and manufacturers submit and maintain their UDI Device Identifiers (UDI-DIs) and related data in the AusUDID.

Patients, consumers, clinical quality registries and health professionals can view this information for free.

No patient information is collected or stored in the AusUDID.

No commercially confidential information is stored in the AusUDID.

Finding medical device information on the AusUDID

You can use the AusUDID to find information about medical devices and in vitro diagnostic devices, such as:

• The different identifiers for a device
• Device information such as brand name, description and a model or version number
• Clinical characteristics, such as size and safety indicators
• Manufacturer details
• Details of the devices’ inclusion on the ARTG
• Packaging information, where applicable
• Related Patient Information Leaflets, where applicable.

You can also view the history of the UDI record and see changes that have happened over time.

All AusUDID data is available at no cost.

Note that not all medical devices supplied in Australia need to have a UDI and that AusUDID data will be built up over time. This means you may not find the UDI record you are searching for. For help in understanding why you cannot find a particular device in AusUDID, you can contact us at UDI@health.gov.au.

The AusUDID provides a range of features to find and download information about a specific medical device.

Searching the AusUDID

Healthcare professionals, patients and the public can use the information in the AusUDID to find out more about the medical devices used on or implanted in you.

You can search and display information by providing information such as:

• the UDI Device Identifier (UDI-DI) found on the device’s label or packaging
• a keyword such as brand name or manufacturer name
• an Australian Register of Therapeutic Goods (ARTG) number or a Global Medical Device Nomenclature (GMDN).

Downloading AusUDID data

You can download information from the AusUDID in several ways. This includes:

• Downloading single UDI records
• Downloading search results
• Downloading the full database
• Downloading the full database periodically: daily, weekly or monthly.

AusUDID environments

There are 2 environments for the AusUDID:

• AusUDID Production
• AusUDID Pre-Production.

Production

The Production environment contains current medical device information that patients, consumers, healthcare and the public can view at no cost.

Sponsors and manufacturers with a TGA Business Services (TBS) account can access the AusUDID Production environment to add and update their UDI records. You can access AusUDID Production here: www.ebs.tga.gov.au.

For information about TBS, see TGA Business Services (TBS) account.

Healthcare professionals and consumers can access the AusUDID via the TGA website.

Pre-Production

The AusUDID Pre-Production environment operates alongside the AusUDID Production environment, serving as an environment for sponsors and manufacturers to:

• familiarise themselves with the AusUDID
• test their respective data submission methods prior to submitting live data to the AusUDID (for example, machine to machine submission).

This AusUDID Pre-Production environment is only available to sponsors and manufacturers, via their TGA Business Services (TBS) account.

As the Pre-Production environment contains the testing and training data for sponsors and manufacturers, patients, consumers, healthcare and the public do not use this environment.

The Therapeutic Goods Administration (TGA) does not guarantee or warrant the accuracy, reliability, completeness, currency or usefulness of the information published in the Pre-Production environment. Only data from the Production environment should be used for any purpose other than testing.

To access the AusUDID Pre-Production environment or for further information, email UDI@health.gov.au.