Episode Details

On September 18, 2026, Japan's PMDA released a major update to its guidance for Software as a Medical Device (SaMD). This episode breaks down the key changes in the revised guide, including new requirements for AI/ML and cybersecurity. We analyze what the new PMDA seminar materials and consultation schedule mean for manufacturers' submission strategies and market access timelines, providing practical steps for regulatory and quality teams to ensure compliance. Key Questions: - What are the most significant changes in Japan's revised 2026 SaMD guidance? - How do the new PMDA seminar materials clarify expectations for AI/ML in medical software? - What are the updated requirements for SaMD cybersecurity documentation in Japan? - How does the new consultation schedule impact market entry timelines for SaMD? - What is a 'Programmatic Improvement Plan' and when is it required for SaMD submissions? - Who is affected by these PMDA SaMD updates? - What practical steps should my regulatory team take right now to prepare? - How do Japan's new SaMD rules compare to international standards? Sources: - https://www.pmda.go.jp/english/whats-new/0003.html - https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0048.html - https://www.gmp-platform.com/topics/pmda_samd_20260918/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies seeking to enter or expand in global markets. Our experts in Japan and over 30 other countries offer localized regulatory strategy, technical dossier preparation using advanced AI, and in-country representation. We help you navigate complex requirements like the PMDA's updated SaMD guidance to ensure efficient and successful market access. For a streamlined path to global compliance, visit https://pureglobal.com or contact us at info@pureglobal.com. Explore our free AI regulatory tools and global device database at https://pureglobal.ai.