Japan PMDA Generative AI: New Draft Criteria for Programmed Medical Devices

Medical Device Global Market Access · Sep 30, 2026 · 6m

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…