Medical Devices Act Article 4
The term "investigational medical devices", as used in this Act, shall refer to medical devices that are used solely in clinical trials and whose therapeutic effect and safety have not been verified.
中文原文 醫療器材管理法第4條
本法所稱試驗用醫療器材，指醫療效能及安全尚未經證實，專供臨床試驗用之醫療器材。