首页 > GHTF标准 > GHTF

GHTF Belgium meeting outcome statement - PDF (31kb)

赵静曼 8/29/2022 浏览 300 GHTF 全球范围

标准简介

Belgium meeting outcome statement - PDF (31kb)[附网盘链接]是The Global Harmonization Task Force发布的GHTF标准，适用于全球范围。

标准截图

Belgium meeting outcome statement - PDF (31kb)[附网盘链接]
Belgium meeting outcome statement - PDF (31kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Belgium meeting outcome statement - PDF (31kb)[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

OUTCOME STATEMENT

of the IMDRF-4 MANAGEMENT COMMITTEE

12 to 14 November 2013

The fourth meeting of the Management Committee of the International Medical Device

Regulators Forum (IMDRF) took place in Brussels (Belgium) from 12 to 14 November 2013.

The meeting was chaired by the European Commission (Directorate General for Health and

Consumers), assisted by appointed representatives of EU Member States (France, Germany

and Ireland). The Management Committee (MC) consists of regulators from Australia, Brazil,

Canada, China, the European Union, Japan, the Russian Federation and the United States of

America. Representatives of the World Health Organization (WHO) participated as official

observers and regulators from Argentina attended as invited observers.

The Management Committee discussed the significant progress achieved on the six on-going

work items:

a. the review of the National Competent Authorities Report Exchange Program;

b. the roadmap for Implementation of Unique Device Identification system;

c. the Medical Device Single Audit Program;

d. the List of Recognized Standards;

e. the Regulated Product Submission; and

f. the Software as a Medical Device.

On the second day, there was an open Stakeholder Forum with more than 100 participants

representing regulators, the medical devices industry, the medical professionals, patients and

the research community. Participants had an opportunity to hear updates on the regulatory

situation in the eight jurisdictions of the Management Committee members. In addition,

update reports were provided on IMDRF’s priority work items and stakeholders had an

opportunity to share their views and ideas on the work of the IMDRF.

In the afternoon, stakeholders discussed “Innovation for Safety: challenges and

achievements". Five stakeholders’ associations representing the patients, healthcare

professionals, notified bodies and industry (medical devices and in vitro diagnostic medical

devices) were invited to explain how they contribute to the improvement of safety and

performance of these devices and to identify challenges. All stakeholders agreed that no issue

can be solved without common engagement, and that collaborative approach is key to

enhance safety.

On the final day of the meeting, the Management Committee discussed matters arising from

the open Stakeholder Forum including how to improve the operation of the Forum so that it

delivers input to the IMDRF work and adopted the revised Standard Operating Procedures.

In 2014, the Chair will be held by the US FDA. The IMDRF-5 meeting will take place in San

Francisco on 25-27 March 2014. Details of the Stakeholder Forum will be communicated on

the IMDRF website, including a theme for possible presentations by stakeholders on that

occasion. The European Union will publish on the IMDRF website (www.imdrf.org) an

网盘链接

百度网盘：https://pan.baidu.com/s/18ojbEPoCWqFIZ4TJ8yx-fw
提取码：e7fm

【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：60.4974 毫秒

相关评论

相关文章