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Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework: A third UDI consultation paper from the TGA (Australian Therapeutic Good Administration)

On 31 August 2022, the Australian Therapeutic Goods Administration (TGA) published a third UDI consultation paper, Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework.

This third consultation seeks feedback on the details of the proposed regulatory framework and will inform the policy decisions that will be made by the Australian Government.

Responses close on 11 October 2022. Please submit a response to the publication TGA Consultation Hub: https://buff.ly/3pZRMdQ

As part of the UDI program, the TGA has also made an early version of the Australian UDI database (the ‘Sandpit’) available to enable all users to provide feedback on the usability and design of the database.

Please see the TGA’s UDI hub for more information or to register for Sandpit access: https://buff.ly/3ADWtyy

You can also contact the TGA UDI Support team directly at UDI@health.gov.au.

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