Australia’s TGA is currently reforming the regulation of software-based medical devices, with an amendment that introduces significant regulatory carve-outs taking effect this week after being postponed due to the COVID-19 pandemic. In support of the changes found in the amendment, the TGA has published guidance on the regulation of clinical decision support software (CDSS) on its website. This guidance document has been published as a draft, and the TGA invites stakeholders to provide feedback in order to facilitate any needed revisions.

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. CDSS that does not meet the definition of a medical device, or is excluded, is not subject to regulation by the TGA.

The CDSS guidance document assists sponsors and manufacturers in determining whether a CDSS product meets the definition of a medical device, and if so, whether it fits the criteria for exclusion or exemption from regulation. Several examples of different software functions are provided in order to demonstrate the application of exemption criteria. Instructions are then given on how to proceed depending on whether the CDSS product is exempt.