Regulation of software based medical devices

TGA

15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device.

The TGA has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device in its own right. 

The guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device - SaMD) that take effect from 25 February 2021.

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Michael Wonder

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Michael Wonder

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Regulation , Australia , Software