体外诊断（IVD）医疗设备分类原理【IMDRF】
祝领导生日快乐 IMDRF/IVD WG/N64FINAL:2021FINAL __TTitle: 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 u of this document; however, incorporation of this document, inpart or in whole, into another document, or its translation into languages other than English, does notconvey or reprent an endorment of any kind by the International Medical Device RegulatorsForum.Copyright © 2021 by the International Medical Device Regulators Forum
光信号灯不亮 IMDRF/IVD WG/N64 FINAL: 2021Page 2 of 1621 January 2021Table of Contents1.0 Introduction. 42.0 Rationale, Purpo 42. 42. 52.3 Sc
排比句的定义>高保真音响. 53.54. 65.0 96.0 mendations and Factors Influencing IVD Medical . 107.0 Propod General Classification System for IVD 108.0 The Determination of 129.0 12
油豆腐皮 IMDRF/IVD WG/N64 FINAL: 2021Page 3 of 1621 January 2021PrefaceThe document herein was produced by the International Medical Device Regulators Forum(IMDRF), a voluntary group of medical device regulators from around the world. Thedocument has been subject to consultation throughout its development.There are no restrictions on the reproduction, distribution or u of this document; however,incorporation of this document,
in part or in whole, into any other document, or its translationinto languages other than English, does not convey or reprent an endorment of any kindby the International Medical Device Regulators Forum.
IMDRF/IVD WG/N64 FINAL: 2021Page 4 of 1621 January __.0 IntroductionThe objective of the International Medical Device Regulators Forum (IMDRF) is toencourage convergence at the global level in the evolution of regulatory systems for medicaldevices in order to facilitate trade whilst prerving the right of participating members toaddress the protection of public health by regulatory means considered to be most suitable.The primary way in which the IMDRF achieves its goals is through the production ofharmonized guidance documents suitable for implementation or adoption by memberRegulatory Authorities, as appropriate taking into account their existing legal framework, orby nations with developing regulatory programmes.This guidance document is one of a ries that together describe a global regulatory model formedical devices. Its purpo is to assist a manufacturer to allocate its In Vitro Diagnostic(IVD) medical device to an appropriate risk class using a t of harmonized principles.Regulato
诚实的反义词是什么>酿酒坊ry Authorities have the responsibility of ruling upon matters of interpretation for aparticular medical device.This document should be read in conjunction with the GHTF document “Principles ofConformity Asssment for IVD medical devices” that mends conformity asssmentrequirements appropriate to each of the four (4) risk class propod herein. The linkbetween new document on classification and conformity asssment is important to ensure aconsistent approach across all countries/regions adopting the global regulatory mended by the IMDRF, so that premarket approval for a particular device may eacceptable globally. Regulatory Authorities who may have different classification proceduresare encouraged to adopt this IMDRF guidance as the opportunity permits.This document has been developed to encourage and support global convergence ofregulatory systems. It is intended for u by Regulatory Authorities, Conformity AsssmentBodies and industry, and will provide benefits in establishing, in a consistent way, aneconomic and effective approach to the control of medical devices in the interest of publichealth.Regulatory Authorities that are developing classification schemes or amending existing onesare encouraged to consider the adoption of the system described
in this document, as this willhelp to reduce the diversity of schemes worldwide and facilitate the process of harmonization.This document superdes an earlier version produced under the Global Harmonization TaskForce (GHTF) with the same title dated February 19, 2008 (GHTF/SG1/N045:2008).2.0 Rationale, Purpo and Scope2.1 RationaleThis guidance document is one of a ries that together describe a global regulatory model formedical devices. It provides guidance on the principles of classification of IVD medicaldevices.
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