Australia TGA CDSS Exemption 2026: What SaMD Manufacturers Need to Know

Medical Device Global Market Access · Sep 14, 2026 · 5m

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: -…