This guidance is for sponsors, manufacturers, suppliers, and software developers of Exempt Clinical Decision Support Software (CDSS) and provides detailed interpretation of the exemption criteria for certain CDSS. This document complements the general guidance on CDSS that was published by the TGA in February 2021.
About this guidance
Scope of regulated Clinical Decision Support Software
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.