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Japan PMDA SaMD Guidance: Key Changes from the June 2026 Update
On June 5, 2026, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its core guidance for Software as a Medical Device (SaMD). This episode breaks down the key changes, including new requirements for AI/ML validation, heightened cybersecurity expectations, and clarified classification rules. We explore how these updates will impact regulatory strategies, submission timelines, and what practical steps SaMD manufacturers should take to ensure compliance and successful market access in Japan. Key Questions: - What specific changes did the PMDA make to its SaMD guidance on June 5…
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