体外诊断医疗器材查验登记须知中英文版.PDF

100.5.23 體外診斷醫療器材查驗登記須知中英文版 中 文 英文翻譯 體 外 診 斷 醫 療 器 材 查 驗 登 記 須 知 Guidelines for Registration of In Vitro Diagnostic Medical Device 壹 、 前 言 Chapter I. Introduction 體外診斷醫療器材查驗登記應依醫療器材查驗登記 The Registration of In Vitro Diagnostic Medical Device (IVD) shall be done according 審查準則及相關規定辦理。本須知所稱體外診斷醫療 to Guidelines for Registration of Medical Devices and relevant regulations. In the 器材（In Vitro Diagnostic Device, IVD ）係指蒐集、準 present guidance, In vitro diagnostic medical device (IVD) are those reagents, 備及檢查取自於人體之檢體，作為診斷疾病或其他狀 instruments, and systems intended for use in the diagnosis of disease or other 況（含健康狀態之決定）而使用之診斷試劑、儀器或 conditions, including a determination of the state of health. Such products are intended 系統等醫療器材。體外診斷試劑係指前述之任何試 for use in the collection, preparation, and examination of specimens taken from the 劑、校正物質或對照物質。 human body. While “In Vitro Diagnostic Reagents” are referring to reagent, calibrator or control material for the above described purpose. 為了加強對於體外診斷醫療器材之管理，確保體外診 To facilitate an effective regulatory control of IVD, ensuring the safety and 斷醫療器材之安全性及功效性，特制定本須知，作為 effectiveness of such products, the present guidance by Department of Health, 第二等級及第三等級體外診斷醫療器材查驗登記審 Executive Yuan (DOH) aims to provide supplementary information on registration of 查之補充規定。第二等級及第三等級體外診斷醫療器