This episode of ASEAN MedTech Insights dives into the regulatory landscape for AI-driven diagnostic tools in Thailand. As artificial intelligence transforms healthcare, many innovators wonder if specific, fast-tracked pathways exist for their technology in key ASEAN markets. We demystify the Thai FDA's position on this critical topic. We reveal that instead of a separate "AI pathway," Thailand employs a sophisticated, risk-based framework for Software as a Medical Device (SaMD). This episode unpacks the classification system, explains the critical documentation required for AI algorithms, and provides real-world examples of how different AI tools are assessed based on patient risk. Case Study: Imagine your company has developed a groundbreaking AI algorithm that detects early-stage diabetic retinopathy from fundus images, promising to save millions from blindness. But submitting it to the Thai FDA is a maze. Is it a Class B or Class C device. What specific data on your algorithm's validation do they need. A misstep in classification could mean months of delays and lost revenue, while your competitors gain ground. What you'll learn in this episode: 1. Why doesn't the Thai FDA have a dedicated "AI-only" regulatory pathway. 2. How is Software as a Medical Device (SaMD) classified in Thailand, and what does it mean for your AI tool. 3. What's the critical difference between an AI that "informs" a clinical decision versus one that "drives" it. 4. What specific documentation regarding your algorithm and data sets will Thai regulators demand. 5. How can you leverage the international IMDRF framework to streamline your submission in Thailand. 6. What are the key cybersecurity considerations you must address in your technical dossier. 7. How does the risk classification of your AI tool impact your time and cost to market entry. At Pure Global, we specialize in demystifying these complex regulatory landscapes. Our end-to-end solutions, combining local expertise in over 30 markets with advanced AI tools, help MedTech and IVD companies streamline global market access. Don't let regulatory hurdles slow your innovation. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your entry into the ASEAN market.