Sponsor and manufacturer obligations in meeting UDI requirements

Sponsors and manufacturers share the responsibilities for meeting UDI requirements. These obligations are in addition to existing regulatory requirements for Australia and do not override or replace them.

Manufacturer role and obligations

Your key obligations include:

• choose a TGA recognised Issuing Agency to issue identifiers for your device
• allocate identifiers to your device using the relevant coding standard set by your chosen Issuing Agency, including:
  • UDI-DI
  • UDI-PI
  • Unit of Use DI, if applicable
  • Direct Marking DI, if applicable
  • Package DI(s), if applicable
• ensure your production processes will apply a UDI Carrier containing the UDI-DI and UDI-PI in HRI and AIDC forms on:
  • the device base package
  • the device itself, if direct marking is applicable
• ensure your production processes will apply a UDI Carrier containing the Package DI and UDI-PI in HRI and AIDC forms to all applicable higher levels of packaging
• allocate a new UDI-DI when there is a change to your device that could lead to misidentification or ambiguity in its traceability (UDI Trigger)
• agree the responsibilities for providing device data and submitting UDI records to the AusUDID with your Australian sponsor and putting these data submission and sharing arrangements in place
• demonstrating compliance with the relevant Essential Principles for your medical device, including those that relate to labelling when requested.

Vala the manufacturer
Vala manufactures Class IIa reusable medical devices. To meet her obligations, she:

• chooses a TGA recognised Issuing Agency

• allocates a UDI-DI, UDI-PI and Direct Marking DI to her devices

• directly marks the reusable device with the UDI

• applies a UDI Carrier containing the UDI-DI and UDI-PI to the base package of the device

• applies a UDI Carrier containing a Package DI and UDI-PI to all applicable higher levels of packaging

• provides the device data to her sponsor to submit to the AusUDID.

Sponsor role and obligations

Your key obligations include:

• confirm your manufacturer has met UDI requirements
• ensuring that your manufacturer has allocated all relevant identifiers to the device
• confirm that the chosen UDI Carrier format is appropriate for the expected use
• agree the responsibilities for submitting UDI records to the AusUDID with your manufacturer and ensuring the data submission and sharing practices are operating and the data is correct
• maintain accurate and up to date UDI records in the AusUDID
• meet applicable record keeping requirements
• ensure compliance with the Essential Principles. 

Sponsor of medical devices supplied by multiple sponsors

If a device has more than one sponsor: 

• your obligations do not change
• you must submit a UDI record, or add sponsor details to an existing UDI record, for the devices you supply.

Third party role and obligations

Manufacturers may choose to allow a third party to apply the UDI Carrier on their behalf. In this circumstance, the manufacturer remains responsible for the conformity of the UDI Carrier. 

Sponsors may choose to allow a third party to submit UDI records on their behalf. In this circumstance, you remain responsible for the data submitted. 

As a third party, you are responsible for ensuring that you meet UDI requirements.