Regulations for the Assessment and Approval Process of Hazardous Medical Device Article 2
The so-called medical device which may cause hazard (hereinafter referred to as hazardous medical device) in the Act means that its use shall be strictly regulated, for any misuse may cause material harm to human health or environmental safety.
中文原文 危險性醫療儀器審查評估辦法第2條
本法所稱具有危險性醫療儀器（以下稱危險性醫療儀器），指其使用應有嚴謹之規範，使用失當可導致人體健康或環境安全重大危害者。