TGA CDSS Exemption Changes: Preparing for the November 1, 2026 Deadline

Medical Device Global Market Access · Oct 1, 2026 · 5m

Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), with significant changes taking effect on November 1, 2026. This episode details the two new mandatory conditions for exemption: the software cannot be intended to make a diagnosis or treatment decision, and its underlying logic must be transparent to the healthcare professional. We explain who is affected, what these changes mean in practice, and the critical steps manufacturers must take to either ensure their product remains exempt or prepare for full TGA…