This episode of ASEAN MedTech Insights unpacks the specific regulatory process for importing and licensing AI-based medical software in Thailand. We explore the Thai FDA's unique requirements, including the crucial "Efficiency Review" for all AI and machine learning technologies, and provide actionable advice for manufacturers looking to enter this dynamic market. We break down the journey through a common scenario: an international company has a proven AI-powered diagnostic software that's successful in other regions. Upon targeting Thailand, they discover their standard technical dossier is insufficient. They now face the challenge of satisfying a specialized Expert Panel that demands rigorous proof of the algorithm's efficacy, safety, and cybersecurity, tailored to the Thai context. How can they bridge this gap and avoid costly delays? Key questions answered in this episode: - What is the official classification for AI-based Software as a Medical Device (SaMD) in Thailand? - Why is the mandatory 'Efficiency Review' the single most critical hurdle for AI device registration? - What specific types of clinical data and validation reports does the Thai Expert Panel expect to see? - How have the 2024 regulatory updates impacted cybersecurity and documentation requirements? - What are the most common pitfalls foreign manufacturers face when submitting their dossiers? - How can a local regulatory partner de-risk your submission and accelerate market access? - What are the key differences between Thailand's requirements and those of other major markets? At Pure Global, we specialize in turning these regulatory complexities into clear market access strategies. We offer end-to-end consulting for MedTech and IVD companies, combining deep local expertise in over 30 markets with advanced AI tools to streamline your global expansion. Whether you're a startup or a multinational, we can act as your local representative and manage the entire registration process. Contact us to navigate your entry into the ASEAN market with confidence. Email [email protected] or visit https://pureglobal.com/.