About the AusUDID

The Australian Unique Device Identification Database (AusUDID) stores Unique Device Identification-Device Identifiers (UDI-DIs) and related data about medical devices supplied in Australia. This information is stored in the form of a ‘UDI record’.

Each UDI record links to the relevant inclusion(s) in the Australian Register of Therapeutic Goods (ARTG) to support transparency and device traceability.

The AusUDID is publicly accessible. Patients, consumers, clinical quality registries and health professionals can view device information at any time.

AusUDID Pre-Production and AusUDID Production

The AusUDID has 2 environments. Each environment supports different activities.

AusUDID Production

The AusUDID Production environment - referred to as the AusUDID - is the live database. You must publish your UDI records here to meet UDI compliance requirements. The UDI record must also link to the relevant ARTG inclusion(s).

Patients, consumers, clinical quality registries and health professionals can access this medical device information.

AusUDID Pre-Production

The AusUDID Pre-Production environment runs alongside the live database.

You can use it to familiarise yourself with the AusUDID, including testing of:

• submission methods
• database functionality.

Sponsors or manufacturers using the HL7 SPL machine to machine method to submit data must complete testing in the AusUDID Pre-Production environment before submitting UDI records to the live AusUDID.

Note

Data you submit to the AusUDID Pre-Production environment does not transfer to the AusUDID Production environment.

AusUDID Pre-Production data will not be considered compliant with UDI requirements. It is for testing purposes only.

We do not guarantee or warrant the accuracy, reliability, completeness, currency or usefulness of the information published in the AusUDID Pre-Production environment. Only data from the AusUDID Production environment should be used for any purpose outside the context of testing.

Information stored in the AusUDID

What is stored

A UDI record contains a UDI-DI and related data about the device. This includes:

• device information
• clinical characteristics
• manufacturing details
• clinical characteristics
• packaging and catalogue information.

Note

For a full list of all data elements in the AusUDID, see Australian UDI Data Dictionary.

What is not stored

A UDI record does not store:

• the UDI-Production Identifier (UDI-PI)
• patient information
• commercially confidential information.