体外诊断（IVD）医疗设备分类原理【IMDRF】 IMDRF/IVD WG/N64FINAL:2021FINAL DOCUMENTTitle: Principles of In Vitro Diagnostic (IVD) MedicalDevices ClassificationAuthoring Group: IMDRF IVD Working GroupDate: 21 January 2021Dr Jeong-Rim Lee, IMDRF ChairThis document was produced by the International Medical Device Regulators Forum. There are norestrictions on the reproduction or use of this document; however, incorporation of this document, inpart or in whole, into another document, or its translation into langua
