We have established the Australian UDI Database (AusUDID) as the repository for UDI information.
The device data in the AusUDID will link to the relevant medical device inclusion(s) in the Australian Register of Therapeutic Goods (ARTG).
You will be able to submit and maintain device data in the AusUDID. Patients, consumers, clinical quality registries and health professionals will be able to access this medical device information, at no cost.
The AusUDID will require a link to an active Australian Register of Therapeutic Goods (ARTG) ID for each UDI record.
You will have a range of methods to submit and manage data in the AusUDID, including:
- online using the AusUDID portal
- records in a Microsoft Excel spreadsheet and uploaded using the AusUDID portal
- electronically using a Machine to Machine (M2M) interface using an HL7 SPL format, or
- electronically using a Machine to Machine (M2M) interface using the National Product Catalogue (NPC).
We will publish AusUDID user guides in 2024.
AusUDID and AusUDID Pre-Production
We will launch the AusUDID once the UDI regulations take effect.
A Pre-Production version (test version) of the AusUDID is now available for use by sponsors and manufacturers to test the functionality of the AusUDID.
The AusUDID Pre-Production version will continue after the AusUDID Production is released. It will provide sponsors with an environment to:
- familiarise themselves with the AusUDID
- test data submission methods before submitting live data to the AusUDID.
To access the AusUDID Pre-Production environment or for further information, email UDI@health.gov.au
Submitting data to the AusUDID using a spreadsheet
The AusUDID will allow the submission of UDI records through a Microsoft Excel sheet. We recommend this method of data submission for organisations with small to medium numbers of UDI records.
Submitting data via HL7 SPL
The AusUDID will allow for Machine to Machine (M2M) submission using a message format compliant with the HL7 Structured Product Labelling (SPL) standard.
We recommend this method of data submission for organisations with larger numbers of UDI records.
More information about HL7 SPL data submission, including guidance, will be published on the UDI Hub in 2024.
Submitting data via the National Product Catalogue
The AusUDID supports submission of UDI records through the National Product Catalogue (NPC). We recommend this method of data submission for organisations with larger amounts of UDI records, particularly those who already use the NPC.
More information about NPC data submission, including guidance, will be published on the UDI Hub in 2024.
Technical information: AusUDID data elements, rules and permitted values
The AusUDID Data Dictionary includes a list of the fields in the database, including:
- data element names
- descriptions
- permitted values
- other useful metadata.
Any changes to the data elements will be published in a new version of the UDI Data Dictionary on the UDI Hub.
More information, including the Australian UDI Data Dictionary and other technical guidance will be published on the UDI Hub when it is available.
Downloading AusUDID data
The AusUDID will allow searching and downloading of UDI data, including individual records or the full database.