Regulation for Registration of Medical Devices Article 9
In Vitro Diagnostic Device (hereafter referred to as IVD) referred to in this Regulation is a medical device such as diagnostic reagents, instruments or systems used to collect, prepare, and test specimens from human body in order to diagnose disease or other conditions (including a determination of the state of health).
中文原文 醫療器材查驗登記審查準則第9條
本準則所稱體外診斷醫療器材（InVitroDiagnosticDevice,IVD），係指蒐集、準備及檢查取自於人體之檢體，作為診斷疾病或其他狀況（含健康狀態之決定）而使用之診斷試劑、儀器或系統等醫療器材。