What Japan PMDA - Software as a Medical Device (SaMD) and AI Medical Device Guidelines (2026) requires
The Pharmaceuticals and Medical Devices Agency (PMDA) regulates Software as a Medical Device (SaMD) and AI/ML-based medical devices under the Pharmaceutical and Medical Device Act. Requirements include risk classification (Class I-IV), clinical evaluation, cybersecurity, quality management (aligned with JIS Q 13485), and continuous post-market surveillance with change management protocols for adaptive AI models.
Pillar: Medical & Healthcare · Authority: Pharmaceuticals and Medical Devices Agency (PMDA) & Ministry of Health, Labour and Welfare (MHLW) · Version: 1.0.0 · Last updated:
Primary source: https://www.pmda.go.jp/english/
SHA-256 integrity: 8b8ef11e15474e7957dcfd9f0007d73b2cd6582e9f19b3b6fa6d7faa07619117
Primary Citations — 4 traced to source
- PMDA Guidance on Software as a Medical Device (2024, updated 2026)
- MHLW Notification on AI Medical Devices (2025)
+ 2 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/japan-pmda-samd-ai-guidelines-2026.json — 6-field metadata
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- Canonical URL: https://bidda.com/intelligence/japan-pmda-samd-ai-guidelines-2026
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