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IMDRF/IVD WG/N64FINAL:2021 (formerly GHTF/SG1/N045:2008) Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)

赵静曼 4/23/2022 浏览 416 IMDRF/IVD WG/N64 世界范围

标准简介

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)[附网盘链接]是IMDRF IVD Working Group于21 January 2021发布的GHTF标准，适用于世界范围。

标准截图

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)[附网盘链接]
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Principles of In Vitro Diagnostic (IVD) Medical Devices Classification - PDF (213kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

1.0 Introduction

The objective of the International Medical Device Regulators Forum (IMDRF) is to encourage

convergence at the global level in the evolution of regulatory systems for medical devices in

order to facilitate trade whilst preserving the right of participating members to address 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 of

harmonized guidance documents suitable for implementation or adoption by member

Regulatory Authorities, as appropriate taking into account their existing legal framework, or

by nations with developing regulatory programmes.

This guidance document is one of a series that together describe a global regulatory model for

medical devices. Its purpose is to assist a manufacturer to allocate its In Vitro Diagnostic (IVD)

medical device to an appropriate risk class using a set of harmonized principles. Regulatory

Authorities have the responsibility of ruling upon matters of interpretation for a particular

medical device.

This document should be read in conjunction with the GHTF document “Principles of

Conformity Assessment for IVD medical devices” that recommends conformity assessment

requirements appropriate to each of the four (4) risk classes proposed herein. The link between

new document on classification and conformity assessment is important to ensure a consistent

approach across all countries/regions adopting the global regulatory model recommended by

the IMDRF, so that premarket approval for a particular device may become acceptable globally.

Regulatory Authorities who may have different classification procedures are encouraged to

adopt this IMDRF guidance as the opportunity permits.

This document has been developed to encourage and support global convergence of regulatory

systems. It is intended for use by Regulatory Authorities, Conformity Assessment Bodies and

industry, and will provide benefits in establishing, in a consistent way, an economic and

effective approach to the control of medical devices in the interest of public health.

Regulatory Authorities that are developing classification schemes or amending existing ones

are encouraged to consider the adoption of the system described in this document, as this will

help to reduce the diversity of schemes worldwide and facilitate the process of harmonization.

This document supersedes an earlier version produced under the Global Harmonization Task

Force (GHTF) with the same title dated February 19, 2008 (GHTF/SG1/N045:2008).

2.0 Rationale, Purpose and Scope

2.1 Rationale

This guidance document is one of a series that together describe a global regulatory model for

medical devices. It provides guidance on the principles of classification of IVD medical

devices.

Since the inter-relationship between device class and conformity assessment is critical in

establishing a consistent approach to premarket approval across all countries/regions, it should

be read in conjunction with the GHTF document on Principles of Conformity Assessment for

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