首页 > GHTF标准 > PrinciplesLabellingMedical DevicesGHTF

GHTF Principles of Labelling for Medical Devices and IVD Medical Devices - PDF (763kb)

赵静曼 8/24/2022 浏览 250 GHTF 全球

标准简介

Principles of Labelling for Medical Devices and IVD Medical Devices - PDF (763kb)[附网盘链接]由GHTF于过去发布，适用于全球。

标准截图

Principles of Labelling for Medical Devices and IVD Medical Devices - PDF (763kb)[附网盘链接]
Principles of Labelling for Medical Devices and IVD Medical Devices - PDF (763kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Principles of Labelling for Medical Devices and IVD Medical Devices - PDF (763kb)[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

Introduction

The purpose of this IMDRF guidance is to provide globally harmonized labelling principles for

medical devices, including in vitro diagnostic (IVD) medical devices, and support the IMDRF

Essential Principles o f Safety and Performance'. Specifically, this document provides guidance

on the content of the label, instructions for use, and information intended for the patient in order

to support the safe and effective use of medical devices and IVD medical devices by their

intended users.

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

systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies

(CABs), industry, and others, and will provide benefits in establishing consistent labelling

requirements in various jurisdictions. Country-specific requirements for the content of the

labelling should be kept to the minimum and, where they currently exist, eliminated as the

opportunity arises.

Labelling serves to identify a device and its manufacturer, and to communicate information on

safety, use, and performance. In some jurisdictions, “labelling” is referred to as “information

supplied by the manufacturer”. Labelling includes the label, instructions for use, and

information related to the identification, technical description, intended purpose and proper use

of the medical device and IVD medical device, as applicable (Figure 1). It is intended for users

of medical devices and IVD medical devices, both professional and lay persons, as appropriate,

and for relevant third parties.

Figure 1. Elements of Medical Device and IVD Medical Device Labelling

RAs require and specify information that manufacturers are expected to incorporate in the

labelling when the device is placed onto the market, to ensure the safe and effective use of their

product. This guidance provides some of those basic expectations, although RAs may have

additional labelling requirements beyond the scope of this guidance.

' See IMDRF/GRRP WG/N47 FIN AL:2018 Essential Principles o f Safety and Performance o f Medical Devices and

IVD Medical Devices

网盘链接

百度网盘：https://pan.baidu.com/s/1cG391oyWN3sBYohUZVgzBA
提取码：i9mq

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：148.704 毫秒

相关评论

相关文章