Singapore is a leader in the ASEAN MedTech landscape, especially in adopting AI for healthcare. However, the Health Sciences Authority (HSA) has introduced sophisticated new guidelines for AI-powered medical devices that focus on the entire product lifecycle. This creates significant new challenges for manufacturers, who must now plan for continuous validation and post-market changes to their algorithms. In this episode, we explore a critical pain point through a case study of an AI diagnostics company. After successfully launching their product, they face the complex task of updating their learning algorithm. This requires a pre-approved Change Management Plan and rigorous documentation, a hidden hurdle that can drain resources and threaten market access if not handled by experts. This week's key questions: - Why is regulating a learning AI algorithm fundamentally different from a static medical device? - What is the "total product lifecycle approach" that Singapore's HSA now requires? - How does an AI's ability to learn become a major regulatory compliance risk? - What is a Change Management Plan and why is it now critical for your AI device submission in Singapore? - Are you truly prepared for the intense post-market surveillance demands for adaptive AI? - What are the hidden documentation burdens for AI devices that could derail your launch? - How can you prove your updated algorithm is still safe and effective? - What kind of clinical governance is needed to deploy an AI medical device in a hospital setting? Navigating the complexities of global MedTech regulations is a major challenge. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and advanced AI tools to streamline your market access. From developing your initial regulatory strategy and managing technical dossiers to acting as your local representative, we clear your path to market. Contact us to learn how we can help you launch and scale in over 30 markets. Email us at [email protected] or visit https://pureglobal.com/.