TGA Australia

The Australian Therapeutic Goods Administration (TGA) has made significant progress in implementing the Unique Device Identification (UDI) system for medical devices.

We are pleased to share these important updates with you:

Publication of the UDI Guidance Draft:

• • On December 12, 2024, the TGA published the draft guidance titled “Complying with the Unique Device Identification regulations for medical devices” for external review.
    This guidance aims to assist sponsors and manufacturers in understanding their regulatory obligations under the Therapeutic Goods Act.
  • Download the guidance.

Updates to the Australian UDI Database (AusUDID):

• • On November 27, 2024, significant improvements were implemented in the pre-production environment of the AusUDID.
    These include:
    • Support for multiple sponsors for the same medical device,
    • Adjustments to the database structure, and
    • Bug fixes.

    The updated bulk upload template (Version 2.3) is now available on the AusUDID portal.

  • Download template.

Consultation on Multi-Sponsorship

The TGA conducted consultations to explore the possibility of allowing multiple sponsors to register the same medical device in the AusUDID.
This aims to enhance the database’s flexibility and accuracy.

Impact on Sponsors and Manufacturers

Sponsors and manufacturers are encouraged to review the draft UDI guidance and provide feedback.
The pre-production environment of the AusUDID is now open for testing and feedback.
It is crucial to use the updated bulk upload template and prepare for the upcoming changes to ensure compliance with the new UDI regulations.