Unlocking Global Markets: SaMD, AI, and Regulatory Fast-Tracks

Medical Device Global Market Access · Jun 4, 2025 · 4m

This episode provides a comprehensive guide to navigating the complex global regulatory landscape for Software as a Medical Device (SaMD), with a special focus on AI-enabled technologies. We explore SaMD risk classifications in key markets like the US, EU, and Canada, discuss recent AI-specific guidance from bodies like the FDA (including the December 2024 updates and PCCPs) and MHRA (June 2024 updates), and highlight available fast-track options. We also offer practical strategies for a successful multi-country SaMD launch in 2025 and beyond. Key Questions: • How do SaMD risk classifications…