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2026년 9월 22일•1분 읽기
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.
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2026년 8월 24일•1분 읽기
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.