Using the Australian UDI Database for healthcare

The AusUDID is Australia's central database for device information and is linked to the Australian Register of Therapeutic Goods (ARTG). Healthcare organisations can use the AusUDID to look up device information, check clinical characteristics such as MRI safety status, identify manufacturer and sponsor details, and access supporting documents where available.

The AusUDID does not contain any patient information.

You can access the AusUDID at https://ausudid.tga.gov.au/.

The Australian Register of Therapeutic Goods (ARTG)

The Australian Register of Therapeutic Goods (ARTG) is the TGA’s public repository of therapeutic goods approved to be legally supplied in Australia. An entry in the ARTG includes information such as:

• sponsor
• manufacturer
• Global Medical Device Nomenclature (GMDN) classification code
• risk classification
• functional description
• intended purpose.

The ARTG provides approval for legal supply of goods as a ‘kind of medical device’. Devices are taken to be of the same kind where they have the following characteristics:

• the same sponsor
• the same manufacturer
• the same risk classification
• the same GMDN code.

Each UDI record in the AusUDID links to an ARTG inclusion, showing more granular information about devices supplied in Australia.

You can access the ARTG here: Searching the Australian Register of Therapeutic Goods (ARTG).

How healthcare organisations can use the AusUDID

The AusUDID can support several healthcare activities where reliable device identification is important.

Healthcare providers can search the AusUDID to confirm key details about a medical device. This can assist staff when selecting, using, documenting or investigating a device.

Example

A clinician identifies a UDI-DI for an implanted device from a patient's record.

By searching for the UDI-DI in the AusUDID, the clinician can view information about the implant, including:

• manufacturer details
• device description
• MRI safety status
• associated regulatory information.

Searching for device information

Users can search the AusUDID in several ways, including by:

• UDI-DI (Device Identifier)
• catalogue number
• brand name
• model name
• manufacturer name
• ARTG ID
• Global Medical Device Nomenclature (GMDN) term
• sponsor information
• other keywords.

For more information on searching the AusUDID, see Searching, viewing and downloading UDI records in the AusUDID.

Understanding UDI record information

Each device model in the AusUDID is represented by a UDI record. Not all UDI records will contain all data, as some data is optional or conditionally mandatory. Rules regarding which fields are mandatory and optional are detailed in the Australian UDI Data Dictionary.

Device information may include:

• Device identifiers - all identifiers for the device, including the Primary DI
• Device information - brand name, model or version, and device description
• Manufacturing details - the manufacturer associated with the device
• Clinical characteristics - MRI safety status, sterility details, clinical size, storage and handling
• Production information - production identifier types on the label, such as batch or serial number
• ARTG details - ARTG ID, sponsor, risk classification
• Packaging and catalogue information - packaging configurations, Package DIs, catalogue numbers and sponsor commercial distribution end dates
• Supporting documents - documents included such as Patient Information Leaflets and Instructions for Use
• History - history of the UDI record, including creation date and updates.

Downloading device data

The AusUDID allows users to download device data for analysis, reporting or integration into local systems.

Downloads can be performed for:

• individual UDI records
• selected search results
• the complete database dataset.

For more information on downloading AusUDID data, see: Searching, viewing and downloading UDI records in the AusUDID.

Multiple sponsors of the same device

Where the same device is supplied in Australia by more than one sponsor, there will be a single UDI record in the AusUDID. Each sponsor links their ARTG to the UDI record to reflect their approval to supply that device and can add their sponsor-specific information such as the catalogue number.