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Excluded software

Guidance

Interpretation of software exclusion criteria

Last updated

This guidance aims to assist sponsors, manufacturers, and software developers to understand the boundaries between software that is and is not regulated. 

The document steps through each software exclusion in the Therapeutic Goods (Excluded Goods) Determination 2018 (the excluded goods order). 

It provides information on how to interpret the criteria and whether they apply to your device.

This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/excluded-software

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