首页 > GHTF标准 > GHTF

GHTF Tokyo meeting outcome statement - PDF (57kb)

赵静曼 12/3/2022 浏览 151 GHTF 全球

标准简介

Tokyo meeting outcome statement - PDF (57kb)[附网盘链接]是于不久前发布的GHTF标准，适用于全球。

标准截图

Tokyo meeting outcome statement - PDF (57kb)[附网盘链接]
Tokyo meeting outcome statement - PDF (57kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Tokyo meeting outcome statement - PDF (57kb)[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-7 MANAGEMENT COMMITTEE

24 to 26 March 2015

The seventh meeting of the Management Committee (MC) of the International Medical Device

Regulators Forum (IMDRF) took place in Tokyo (Japan), from 24 to 26 March 2015. The

meeting was chaired by Japan. The 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) and Asia-Pacific Economic

Cooperation (APEC) as an Official Observer and Asian Harmonization Working Party

(AHWP) and Pan American Health Organization (PAHO) as an Affiliate Organization also

participated.

On the first day, the MC discussed the progress achieved on the on-going work items:

1. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

3. Regulated Product Submission (RPS)

4. Software as a Medical Device (SaMD)

5. Medical Device Patient Registries

6. Use of ISO14155: 2011

A Revised New Work Item Proposal (NWIPs) and one NWIP were also presented to

the MC:

1. Development of common terminology and code related to adverse

events of medical devices – Japan MC Delegation

2. List of International Standards recognized by IMDRF Management

Committee Members, Phase II- GMTA

The MC invited MedDRA to make presentation on the proposed collaboration

between IMDRF and MedDRA.

The MC also discussed IMDRF strategic plan to identify its direction for the coming

years to better coordinate its activities and allocate its limited resources. The MC will

finalize the plan in Kyoto meeting in September 2015.

网盘链接

百度网盘：https://pan.baidu.com/s/1M39mPwemI9HYt71JKgITtw
提取码：pfcb

【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：30.8829 毫秒

相关评论

相关文章