Episode Details

Australia's Therapeutic Goods Administration (TGA) has amended the exemption criteria for Clinical Decision Support Software (CDSS), effective November 1, 2026. This episode breaks down the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026, explaining the clarified distinction between exempt software that 'informs' clinical decisions and regulated Software as a Medical Device (SaMD) that 'guides' or 'drives' them. We discuss the direct impact on SaMD manufacturers and provide practical, actionable steps to ensure compliance before the deadline. Key Questions: - What are the key changes to Australia's TGA exemption for Clinical Decision Support Software (CDSS) as of 2026? - When do the new TGA regulations for CDSS take effect? - How can you determine if your software is still exempt or is now a regulated SaMD? - What is the difference between software that 'informs' a clinical decision versus one that 'directs' it under the new rules? - What steps must SaMD manufacturers take if their product no longer qualifies for the exemption? - What are the deadlines for complying with the Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026? - How does this amendment impact the regulatory strategy for digital health products in Australia? - What documentation is needed for an ARTG inclusion application for a newly regulated SaMD? Sources: - https://www.tga.gov.au/news/news/clinical-decision-support-system-exemption-amendments - https://www.legislation.gov.au/F2026L01193/latest/text How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. For companies affected by the TGA's CDSS rule changes, we offer expert services in regulatory strategy, SaMD classification, technical dossier preparation for ARTG inclusion, and QMS compliance. Our team combines local Australian expertise with advanced AI tools to ensure your software meets all regulatory requirements efficiently. Whether you are a startup or a multinational, we can help you navigate the complexities of SaMD regulation and maintain market access in Australia and over 30 other countries. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.