Episode Details

On September 18, 2026, Japan's PMDA published draft review criteria for programmed medical devices (SaMD) that use generative AI, such as LLMs. This episode breaks down the PMDA's key areas of focus, including requirements for defining intended use, managing training data, evaluating model performance, and planning for the device's entire lifecycle. We discuss the implications for manufacturers targeting the Japanese market and outline practical steps that regulatory and quality teams should take now to prepare for these new expectations. Key Questions: - What are the key points in Japan's PMDA draft review criteria for generative AI? - How do these criteria affect SaMD manufacturers using LLMs? - What specific documentation will be required for data management and model validation? - How does the PMDA expect manufacturers to handle the risk of AI "hallucinations"? - What are the expectations for post-market surveillance and lifecycle management of AI models? - When were these draft criteria released? - Who should be reviewing these new requirements within a MedTech company? - What practical steps can your team take now to prepare for submission in Japan? Sources: - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQGS7tN1cIA1hzbk5Pgku_QPQaKho4dBZMZf7sOuRfPkK_E4ErkDthjkboF_arMuwmuQlV11h_YOLdnJol5AvADesIiCkQI6GTi40VfCnj0Hp1GfNpv_1Ac1OTfERKjNsf7CYzbupJdGLZUfmvk= - https://vertexaisearch.cloud.google.com/grounding-api-redirect/AUZIYQHH9MITMgFkIsafJRIb3cUti36PqwtAbD5G0VN7O5ryxzrWyzu1unrdwLEXF62viDnBVAjmkQ0cFAe8Ip7ycPsLDQh028PyGxdRL_La5UYjdvamDx9fA1GKfeQ= How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex requirements for innovative devices like AI-powered SaMD. Our experts develop efficient regulatory strategies and use advanced AI to compile and manage technical dossiers for submission in Japan and over 30 other markets. We act as your local representative and provide continuous regulatory monitoring to ensure you maintain compliance throughout your product's lifecycle. Let us help you accelerate your global market access. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.