Medical Devices Act Article 37
Clinical trial institutions or trial sponsors shall file an application with the central competent authority and obtain its approval before initiating any clinical trial. However, this shall not apply to those that do not involve significant risks as announced by the central competent authority.Clinical trial institutions implementing clinical trials of the preceding paragraph shall exercise the necessary duty of medical care, and shall obtain consent from human subjects except in the case of emergencies.Regulations governing the scope of management, operational practices, application procedures, review guidelines, avoidance of conflicts of interest, information disclosure, supervision and administration, inspection, particulars of the content of informed consent referred to in the preceding two paragraphs, and other matters to be complied with in regard to medical device clinical trials shall be established by the central competent authority.
中文原文 醫療器材管理法第37條
臨床試驗機構或試驗委託者發起醫療器材臨床試驗，應申請中央主管機關核准後，始得為之。
但無顯著風險經中央主管機關公告者，不在此限。
臨床試驗機構執行前項試驗，應善盡醫療上必要之注意，除情況緊急者外，應先取得受試者之同意。
前二項醫療器材臨床試驗之管理範圍、作業規範、申請程序、審查基準、利益迴避、資訊揭露、監督管理、查核、受試者同意書應記載內容及其他應遵行事項之辦法，由中央主管機關定之。
但無顯著風險經中央主管機關公告者，不在此限。
臨床試驗機構執行前項試驗，應善盡醫療上必要之注意，除情況緊急者外，應先取得受試者之同意。
前二項醫療器材臨床試驗之管理範圍、作業規範、申請程序、審查基準、利益迴避、資訊揭露、監督管理、查核、受試者同意書應記載內容及其他應遵行事項之辦法，由中央主管機關定之。