Pure Global: Singapore's AI MedTech Rules & The 'Living Dossier' Headache

In the final days of 2025, Singapore's Health Sciences Authority (HSA) launched a new regulatory framework for AI-powered medical devices, introducing the concept of a "Living Dossier." This move signals a major shift from one-time approvals to continuous lifecycle management, creating significant new compliance challenges for MedTech companies targeting the ASEAN market. This episode unpacks what these new post-market surveillance and algorithm change management rules mean for the industry. We explore the operational and financial burdens of maintaining a "Living Dossier" and discuss how this Singaporean benchmark could influence regulations across Southeast Asia. Consider "CardioPredict AI," a Thai startup with an approved cardiac risk algorithm. Their plans for a swift Singapore launch are now on hold. They face the unexpected and costly challenge of building a system for continuous algorithm monitoring and reporting to meet the HSA's new requirements, putting their funding and expansion timeline at risk. 本期干货: 1. What is the "Living Dossier" and why is it a game-changer for AI device regulation? 2. How do the new rules on algorithm change management impact your product roadmap? 3. Are your current post-market surveillance plans adequate for these new standards? 4. What specific real-world performance data will you need to collect and report? 5. How can you prove your AI model avoids bias with diverse patient population data? 6. Could this new Singaporean standard become the benchmark for the entire ASEAN region? 7. What are the three immediate steps to take if your AI device is already on the market? 8. How can you turn this new regulatory hurdle into a competitive advantage? Navigating complex, fast-changing regulations is our specialty. Pure Global offers end-to-end regulatory consulting, from initial strategy and technical dossier submission to continuous post-market surveillance. Our blend of local expertise and advanced AI tools helps you maintain market presence and turn compliance into a strategic asset. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.