首页 > GHTF标准 > GHTF

GHTF Sydney meeting outcome statement - PDF (63kb)

赵静曼 11/26/2022 浏览 147 GHTF 全球范围

标准简介

Sydney meeting outcome statement - PDF (63kb)[附网盘链接]是GHTF于之前发布的GHTF标准，适用于全球范围。

标准截图

Sydney meeting outcome statement - PDF (63kb)[附网盘链接]
Sydney meeting outcome statement - PDF (63kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Sydney meeting outcome statement - PDF (63kb)[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 Management Committee

25 to 27 September 2012

The second meeting of the International Medical Device Regulators Forum (IMDRF) was

held in Sydney from 25 to 27 September 2012. The Management Committee (MC) meeting

was attended by regulators from Australia, Brazil, Canada, Europe, Japan and the United

States of America. Regulators from China as well as representatives from the World Health

Organization (WHO) and the Chair of the Asian Harmonization Working Party (AHWP) also

attended. A representative from Singapore’s Health Sciences Authority and New Zealand’s

Medsafe joined the meeting as Invited Observers.

This was an important meeting to further progress IMDRF’s priority work items. On the first

day of the Forum the MC met to discuss progress relating to:

a. Review of the NCAR system;

b. Roadmap for Implementation of UDI system;

c. Medical Device Single Audit Program;

d. Recognized standards; and

e. Regulated Product Submission

The MC also held a special session with representatives from the Global Medical Technology

Alliance (GMTA) and the Global Diagnostic Imaging, Healthcare IT and Radiation Therapy

Trade Association (DITTA) to discuss key issues, including industry engagement with

regulators and industry expectation of IMDRF processes, as well as key issues for the

medical device/technology sector over the next 5–10 years. Other discussion items included

trends in medical device/technology innovation and global manufacturing, proposed changes

in global regulation as well as issues regarding supply-chain integrity.

The MC agreed on an IMDRF website prototype, which is currently in development.

The second day of the Forum was an open day attended by over 80 stakeholders representing

a range of sectors. The Forum was provided with member/jurisdictional updates. In addition,

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

opportunity to share their views and ideas on key issues.

On the final day of the meeting, matters arising from the Open Stakeholder Forum were

discussed by the MC. The MC also considered issues relating to IMDRF’s Operating

Procedures.

网盘链接

百度网盘：https://pan.baidu.com/s/1_otkZG5QByGiirglY9OdPg
提取码：us66

【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：39.7011 毫秒

相关评论

相关文章