Episode Details

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 regulation as a medical device. Key Questions: - What are the new TGA requirements for the CDSS exemption taking effect in 2026? - How does the TGA define the difference between software that 'informs' versus 'makes' a clinical decision? - What does it mean for a CDSS to make its underlying logic 'visible' to a healthcare user? - Which types of software are most likely to lose their exempt status on November 1, 2026? - What is the deadline for complying with the new Australian CDSS rules? - What are the immediate actions regulatory teams should take to assess their CDSS products? - If my software no longer qualifies for the exemption, what is the process for TGA registration? - How can we update our intended purpose statement to align with the new criteria? Sources: - https://www.tga.gov.au/news/news/clinical-decision-support-system-exemption-amendments - https://www.cliniccomply.com.au/p/tga-cdss-changes-1-november-2026 - https://medtechconnect.org.au/article/september-14th-18th-2026/ How Pure Global can help: Pure Global provides comprehensive regulatory consulting for MedTech and IVD companies seeking to navigate complex international markets like Australia. Our experts can help you conduct a gap analysis of your CDSS against the new TGA criteria, refine your intended purpose, and prepare all necessary technical documentation for a TGA submission if your product requires registration. By combining local expertise with advanced AI technology, we streamline the process of achieving and maintaining compliance, ensuring you can access global markets faster. For support with your regulatory strategy, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and global device database at https://pureglobal.ai.