Changes to the way that software-based medical devices are regulated in Australia came into effect on 25 February 2021. Information about the changes can be found in Regulatory changes for software based medical devices.

Clinical decision support software (CDSS) that meets the definition of a medical device must be included in the Australian Register of Therapeutic Goods (ARTG) unless otherwise exempt. Under the changes, an exemption has been introduced for some CDSS that is a medical device. Note, CDSS that does not meet the definition of a medical device, or is excluded, is not subject to regulation by the TGA.

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