Involving health professionals, healthcare organisations, consumers and industry in the development and implementation of the UDI system is critical to its success. The TGA will engage and consult with stakeholders to ensure that all perspectives, particularly those of consumers who use medical devices, are taken into account. Public reporting by the TGA will ensure that progress towards implementing the UDI system is transparent to all.
Consultations and forums
The TGA will continue to undertake a series of consultations to inform the planning and design of the Australian implementation. Each consultation will be designed to cover key topic areas that we will need to consider as we progress with our planning.
The consultation process may include consultation papers, stakeholder workshops, discussions and working groups. You can view the previous consultation papers via the links below:
- UDI Consultation Paper 1 (2019) - Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
- UDI Consultation Paper 2 (2020) - Exploring options for the introduction of an Australian Unique Device Identification (UDI) System
- UDI Consultation Paper 3 (2022) - Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework
We will use our established forums including the Regulatory and Technical Consultative Forum for medical devices (RegTech Forum).
Webinars
We host regular UDI webinars covering a range of topics, such as introductory UDI information (for those new to UDI as a concept) to UDI software information. Sponsors, manufacturers, patients, or healthcare professionals can attend our live webinars, or you may wish to watch our previous webinar recordings.
Please email UDI@health.gov.au if you have any questions or wish to be notified of upcoming UDI webinars.
Past webinars
View the presentation slides or webinar recordings.
- Unique Device Identification Webinar #16, 29 March 2023
UDI in the Supply Chain, Inventory Management and Procurement - Michel Hulzebos and Joanna Giannone, Healthscope - Unique Device Identification Webinar #15, 21 February 2023
Benefits and considerations for UDI in Healthcare - Dr Oliver Daly, Western Health Chief Medical Informatics Officer - Unique Device Identification Webinar #14, 18 October 2022
Observations and learnings from the UK Scan4Safety pilot - Brett Newstead, Zebra Technologies Director - Unique Device Identification Webinar #13, 20 September 2022
UDI Consultation Paper 3 information and submission process - Michelle van Wijk, UDI Project Manager - Unique Device Identification Webinar #12, 16 August 2022
Questions from the Australian UDI database (AusUDID) Sandpit environment and update on UDI Consultation Paper 3 - Michelle van Wijk, UDI Project Manager and Gary Pascoe, UDI Product Owner - Unique Device Identification Webinar #11, 19 July 2022
Accessing and providing feedback on the Australian UDI database (AusUDID) Sandpit Environment - Gary Pascoe, UDI Product Owner - Unique Device Identification Webinar #10, 21 June 2022
Accessing and using the Australian UDI database (AusUDID) Sandpit environment - Gary Pascoe, UDI Product Owner - Unique Device Identification Webinar #9, 17 May 2022
Real world experience using UDIs in Healthcare - Mark Songhurst, Leeds Teaching Hospitals NHS Trust Scan4Safety Programme Lead and Kirk Kikirekov, Prospitalia h-trak Managing Director - Unique Device Identification - Webinar #8, 19 April 2022
Global manufacturer UDI learnings - Roger Peterson, Arthrex Senior Manager of Global Labeling - Unique Device Identification - Webinar #7, 22 March 2022
Global manufacturer UDI learnings - Debbie Connors, Smith+Nephew Senior Director of Regulatory Affairs - Unique Device Identification - Webinar #6, 16 November 2021
UDI Project update - Michelle van Wijk, UDI Project Manager - Unique Device Identification - Webinar #5, 19 October 2021
The role of a UDI Issuing Agency - Allison Mehr, HIBCC Vice President - Unique Device Identification - Webinar #4, 21 September 2021
The role of a UDI Issuing Agency - Geraldine Lissalde-Bonnet, GS1 Director of Public Policy - Unique Device Identification - Webinar #3, 17 August 2021
Challenges and considerations on the journey to a global UDI system - Dennis Black, Becton Dickinson Global UDI Program Director - Unique Device Identification - Webinar #2, 20 July 2021
Further considerations for the Australian UDI, including global alignment, GMDN and data elements - Michelle van Wijk, UDI Project Manager - Unique Device Identification - Webinar #1, 15 June 2021
Introduction to the Australian Unique Device Identification (UDI) System - Tracey Duffy, First Assistant Secretary and Michelle van Wijk, UDI Project Manager (TGA)
Tell us what information you would like to see on the UDI 'Hub' or suggest a webinar topic by emailing us at: udi@health.gov.au
Inform and involve
We will continue to engage broadly across the healthcare system, from supply, procurement, and distribution through to clinical use, patient use, registries and the use of device information for post-market analysis and research.
You can keep informed by:
- visiting this page for updates
- contacting the TGA UDI team at udi@health.gov.au
- subscribing to the TGA Update email list
- connecting with us on social media.
Contact us
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Medical Devices Surveillance Branch |