首页 > GHTF标准 > MaintenanceIMDRF/AE WG/N44

IMDRF/AE WG/N44FINAL:2020 (Edition 3) Maintenance of IMDRF AE Terminologies - PDF (384kb)

赵静曼 3/11/2022 浏览 274 IMDRF/AE WG/N44 全球

标准简介

Maintenance of IMDRF AE Terminologies - PDF (384kb)[附网盘链接]是IMDRF Adverse Event Terminology Working Group于18 March 2020发布的GHTF标准，适用于全球。

标准截图

Maintenance of IMDRF AE Terminologies - PDF (384kb)[附网盘链接]
Maintenance of IMDRF AE Terminologies - PDF (384kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Maintenance of IMDRF AE Terminologies - PDF (384kb)[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 Adverse Event Working Group (“AE WG”) organized under International Medical Device

Regulators Forum (“IMDRF”) has developed a harmonized terminology for reporting adverse

events (“IMDRF AE Terminology”) that are known or suspected to be linked to the use of

medical devices and in vitro diagnostics.

Globally harmonized terminologies for adverse event reporting are a key requirement for more

effective reporting, analysis and information exchange of adverse events and will reduce the

burden for manufacturers and other reporters (e.g., sponsors).

Once developed and agreed upon, there will be a clear need for an agreed approach for

maintenance of these terminologies, ensuring adjustments that may be required over time,

especially for:

a) technical updates and innovations (e.g., new devices, materials)

b) other developing needs of intended users, such as AE reporters and regulatory authorities

The AE WG has considered the options for ongoing maintenance of the IMDRF AE

Terminology. This document is intended to describe the basic procedures that should be followed

in order to ensure the IMDRF AE Terminology remain up-to-date, adequate, and accurate

following their initial publication.

2.0 Scope

This document sets forth the basic procedures for revising the IMDRF AE terminology described

in Annexes A through G of the IMDRF document entitled, “IMDRF terminologies for

categorized Adverse Event Reporting (AER): terms, terminology structure and codes

(IMDRF/AE WG/N43)”.

3.0 Reference

 IMDRF/AE WG/N43 - IMDRF terminologies for categorized Adverse Event Reporting

(AER): terms, terminology structure, and codes

4.0 Definition

“Member Jurisdiction” shall mean the jurisdiction to which a member of the AE Terminology

Maintenance WG belongs.

“National Competent Authority” shall mean any duly authorized regulatory authority affiliated

with a national or regional entity, which is tasked with regulating medical devices and in vitro

diagnostics in its jurisdiction.

18 March 2020 Page 4 of 7

网盘链接

百度网盘：https://pan.baidu.com/s/1KA2jOtvGBpdn7sxPzUiA0Q
提取码：n8r7

【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：86.2024 毫秒

相关评论

相关文章