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Regulatory changes for software based medical devices

This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device).

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This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device - SaMD) that took effect from 25 February 2021. It outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

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This webpage on the TGA website was printed on 10 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 Printed content may be out of date.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/regulatory-changes-software-based-medical-devices

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