Medical Care Act Article 8
This English translation was last updated on 2023-06-28, but the Chinese text was amended on 2026-09-23. Later amendments may not be reflected in the translation — please refer to the Chinese text.
The term “human trial” as used in the Act shall refer to experimental research of new medical technology, new medicament, new medical implement, or the bioavailability and bioequivalence of generic drugs conducted by medical care institutions on humans based on medical theory.In conducting a human trial, the medical care institution shall respect the voluntary intent of the trial subjects and protect their right to health and privacy.
中文原文 醫療法第8條
本法所稱人體試驗，係指醫療機構依醫學理論於人體施行新醫療技術、新藥品、新醫療器材及學名藥生體可用率、生體相等性之試驗研究。
人體試驗之施行應尊重接受試驗者之自主意願，並保障其健康權益與隱私權。
人體試驗之施行應尊重接受試驗者之自主意願，並保障其健康權益與隱私權。