Medical Devices Act Article 5
The term "medical device clinical trials", as used in this Act, shall refer to the systematic studies on the safety or effectiveness of medical devices carried out in human subjects by medical care institutions or institutions announced by the central competent authority (hereinafter referred to as "clinical trial institutions").
中文原文 醫療器材管理法第5條
本法所稱醫療器材臨床試驗，指醫療機構或經中央主管機關公告之機構（以下簡稱臨床試驗機構），對受試者所為有關醫療器材安全或效能之系統性研究。