Japan PMDA SaMD Guidance: 2026 Update and Submission Strategy

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-04

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...