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Status Update for Australia TGA UDI

Aug 3, 2022 | Medical Devices, Unique Device Identification

The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing UDI compliance


News of note:

TGA has announced that they will have a similar model to the FDA, adopting some elements of the EUDAMED model
• A third consultation is planned for the end of this year
• Voluntary compliance to begin January 2023

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 ‘Sandpit’ UDI pilot. Reed Tech would be happy to join you as a technical partner if you wish to participate.


TGA UDI Information (materials)

UDI Timing

TGA UDI Information (website)

Listen to this quick 6-minute update, recorded July 2022:

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™.

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