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Regulatory changes for software based medical devices
In effect from 25 February 2021
24 February 2021
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Description
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.
Contents
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