Posted by Michael Wonder on 15 Jan 2021
Regulation of software based medical devices
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.
