Is Australia Therapeutic Goods Administration (TGA) making progress on Unique Device Identification (UDI) requirements? The answer is yes! There are several progress milestones that have been reached. The Australia TGA website has posted a number of updates to help inform the public of their process. See the convenient links below to learn more.
You may wish to subscribe to the TGA email list or participate in the upcoming Queensland UDI pilot. Reed Tech would be happy to join you as a technical partner if you wish to participate.
Legislation/Regulation
- 2019-Jan-07 Australian TGA released proposal for UDI System
- 2019-Apr-04 TGA UDI Action Plan
- 2020-Sep-23 TGA opened UDI Consultation Survey
- 2020-Oct-06 Gov’t approved $7.7 million for TGA AusUDID
- 2021-Feb-19 Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020, create AusUDID
TGA UDI Information (materials)
- 2018-Jan-07 TGA UDI Consultation #1
- 2021-May-19 TGA UDI Consultation #2 web survey with results
- 2021-Jun-15 TGA UDI Webinar #1
- 2021-Jul-20 TGA UDI Webinar #2
- 2021-Aug-21 TGA UDI Webinar #3
UDI Timing
- Timing is TBD, TGA is currently resolving UDI implementation issues
- “Australia does not plan to implement before the EU dates.”
TGA UDI Information (website)
- Medical device reforms: Establishment of a UDI system; Overview, links
- TGA Unique Device Identification system (UDI home page): Benefits, Progress, News
- TGA UDI Action Plan Progress (webpage): History, Progress, Communication, Timing
- TGS UDI Communication (webpage): Forums, Webinars, Subscribe to TGA email list
TGA UDI Pilot
- Queensland is planning UDI pilot – contact TGA UDI team at [email protected]
Listen to this quick 3 minute update:
We will continue to monitor Australia TGA progress for UDI and provide updates. Contact Reed Tech to see how product data management can be handled effectively and efficiently through flexible team roles and data validation tools in a dedicated solution such as SingleSource™.
Email us: [email protected]