Managing UDI records with multiple sponsors
Learn how to manage UDI records when a device is supplied by more than one sponsor.
Australia’s regulatory model permits 2 or more sponsors to supply the same model of medical device with the same UDI-DI.
When there are multiple sponsors of the same device with the same UDI-DI, all sponsors link to the same UDI record. This avoids multiple versions of the same UDI record and reduces confusion for end users such as healthcare professionals and the public.
When a UDI record has more than one sponsor, UDI data elements are separated into 2 categories:
- device data elements
- sponsor data elements.
Device data elements
Device data elements are common between sponsors, as these are determined by the manufacturer.
If these data elements are also UDI Trigger data elements, they remain UDI Trigger data elements.
Sponsor data elements
Sponsor data elements are specific to each sponsor and can only be edited by the sponsor they relate to.
You can find the data elements categories in the Australian UDI Data Dictionary.
Submitting UDI records with multiple sponsors
As a sponsor, you are responsible for submitting UDI records for your devices.
If you are the first sponsor submitting the UDI record, submit the UDI record as normal.
If another sponsor has already submitted the UDI record, you only need to:
- add your sponsor data, such as ARTG ID and Catalogue Number
- check that the existing device data is accurate and complete.
You do not need to duplicate or resubmit the existing UDI record. Once you add your sponsor data, you meet your UDI submission obligations.
Data elements for multiple sponsors
The AusUDID manages the type of changes to the data according to the type of data element:
- Device data elements must stay consistent for all sponsors of the device. This data should be controlled by, or entered into the AusUDID according to, the manufacturer.
- Sponsor data elements are unique to each sponsor and editable only by that sponsor.
When 2 or more sponsors are linked to a UDI record, icons are displayed to show their categories.
Device data elements are marked with a ‘D’ icon:
Updating or correcting UDI records with multiple sponsors
If you change a UDI record that is linked to multiple sponsors:
- all changes to Device data elements must be recorded as a Correction, even when the data element is not a UDI Trigger
- you must provide a reason for the change.
Change history appears in the UDI record’s History tab.
Responsibility and resolution of data disputes
You are only responsible for the data that you provide:
- If you are the first sponsor to add the UDI record, you are responsible for the UDI record as a whole.
- If you are a subsequent sponsor who links an ARTG ID to the UDI record, you are responsible for ensuring that the data in the UDI record is accurate and up to date at the time of linking your ARTG ID.
If another sponsor changes data incorrectly, you are not responsible for this change. The sponsor who changed the data to be incorrect is responsible. If you believe a change to the UDI record is wrong, contact the UDI Support Team at UDI@health.gov.au.
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