Regulatory Changes for Software Based Medical Devices

On 9 August 2021 the Australian Therapeutic Goods Administration (TGA) published the guidance on 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 - SaMD) that take 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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