Engage on upcoming UDI system changes


Medtech stakeholders can be kept abreast of how the establishment of a new Australian Unique Device Identification (UDI) system will affect their companies through the Therapeutic Goods Administration’s upcoming webcast series.

The introduction of the UDI system offers manufacturers and sponsors, and procurement and supply chain functions, improved abilities to manage inventory through its ability to automatically capture production information by scanning a label and to automatically capture device information, reducing time and risk of data errors and inconsistencies. It also offers improved post-market surveillance due to the ability to unambiguously identify models of devices on a national, regional, and global basis.

Many manufacturers supply to multiple markets and are preparing to meet the new European Union (EU) regulations; the TGA is not planning to implement before the EU dates. The TGA is in its early planning stages for the Australian implementation and has not yet defined the new regulations, regulatory dates or the transition approach. The webcast series will keep stakeholders informed on its progress.

Through its AusMedtech Regulatory Affairs Advisory Group, AusBiotech has been responding to TGA consultations on implementing a UDI system in Australia for more than two years. The Advisory Group also regularly participates through the TGA’s Regulatory & Technical Consultative (RegTech) Forum. This ongoing engagement has supported the TGA in its planning and design of the Australian UDI system.

Previous submissions, most recently in November 2020, support the idea of a UDI system, on the proviso that Australia adopts a globally harmonised system that is consistent with that of the US and EU. This includes ensuring alignment with international coding standards of UDI issuing agencies designated in the US and accredited in the US.

Monthly webinars are being held by TGA. The first webinar is on 11.30 – 12.30 pm (EST), Tuesday, 15 June 2021, and will cover the background to the UDI in Australia and progress to date, and allow time for questions and answers. Register here

Sessions will also be recorded and available on the TGA website.