Starting from 25 February 2021, Australia TGA changed their regulation on software-based medical device with a revision that establishes the qualification for the software to be exempted or excluded. For Clinical Decision Support Software that are under exclusion, this means that the devices are completed unregulated by TGA. For Clinical Decision Support Software that are under exemption, this means that TGA still retains some oversight for advertising, adverse events and notification even though registration of devices is not required.
Clinical decision support software (CDSS) exempted or excluded from TGA regulation
Previously, 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. A new exemption has been added for some CDSS that are medical devices as a result of the revision. CDSS that does not meet the definition of a medical device, or is excluded, is not subject to regulation by the TGA. However, the TGA must be notified when exempted CDSS medical devices are brought into Australian market.
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