Are you a Sponsor or Manufacturer of a medical device on the ARTG? Are you aware of the Unique Device Identification (UDI) regulatory framework that came into effect on 24 March 2025?
With the introduction of UDI, Australia will join a globally harmonised approach that supports more accurate tracking and tracing of medical devices. UDI facilitates traceability through the introduction of a unique device identifier for each model of medical device which will ultimately bring many benefits to strengthening patient safety in Australia.
On Tuesday 30 September, Pharma To Market attended a UDI Launch Workshop in Sydney, run by the TGA. The workshop, presented by Gary Pascoe, UDI Project Lead, was well attended by industry and very well planned and executed by TGA.
Topics discussed included understanding and complying with the UDI requirements, advice on how industry can prepare themselves and understanding the Australian UDI Database (AUSUDID).
If you require support to understand the upcoming changes and how this will affect you, please reach out to us at Pharma To Market. We can help you identify your devices that must comply and their labelling requirements, initiating internal procedures for managing device data and preparation and submission of this data into AUSUDID.
We look forward to continuing the UDI conversation!
And remember – the first UDI compliance date is only 9 months away (1 July 2026)!
For further details regarding UDI, we recommend visiting the TGA UDI hub: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub.