Regulations on Human Trials Article 2
A human trial research (hereinafter “Human Trial” shall be conducted prior to the registration of a new drug or medical device or before a medical care institution lists a new medical technology as a regular medical disposition item.
中文原文 人體試驗管理辦法第2條
新藥品、新醫療器材於辦理查驗登記前，或醫療機構將新醫療技術，列入常規醫療處置項目前，應施行人體試驗研究（以下稱人體試驗）。