規制動向
2026年9月22日•1分で読めます
MFDS Revises Digital Therapeutic Device Clinical Trial Guidelines for 7 Indications
South Korea's MFDS has detailed new review criteria and updated guidelines for digital therapeutic device trials covering seven mental‑health and substance‑use disorders.
規制動向
2026年8月24日•1分で読めます
PMDA Adds Project Team for AI Utilization Guiding Principles
The Pharmaceuticals and Medical Devices Agency (PMDA) announced a new project team to develop guiding principles for AI utilization, listed under its “Projects Across Multi‑Offices” initiative.