首页 > GHTF标准 > GHTF

GHTF France meeting outcome statement - PDF (60kb)

赵静曼 9/21/2022 浏览 205 GHTF 全球

标准简介

France meeting outcome statement - PDF (60kb)[附网盘链接]由The Global Harmonization Task Force于不久前发布，适用于全球。

标准截图

France meeting outcome statement - PDF (60kb)[附网盘链接]
France meeting outcome statement - PDF (60kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为France meeting outcome statement - PDF (60kb)[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-3 MANAGEMENT COMMITTEE

19 to 21 March 2013

The third meeting of the International Medical Device Regulators Forum (IMDRF) took

place in Nice and Sophia Antipolis (France) from 19 to 21 March 2013. The meeting was

chaired by the European Commission (Directorate General for Health and Consumers),

assisted by representatives of European Member States (France, Germany and Poland). The

1

Management Committee (MC) consists of regulators from Australia, Brazil, Canada, China ,

the European Union, Japan and the United States of America. Representatives of the World

Health Organization (WHO) participated as official observers and regulators from the

Russian Federation and from Mexico attended as invited observers. Asian Harmonization

Working Party (AHWP) participated as affiliate organization.

The Management Committee discussed the significant progress achieved on the five 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; and

e. the Regulated Product Submission.

On the second day, there was an open Stakeholder Forum with about 130 participants from

organizations representing regulators, the medical devices industry, the medical

professionals, patients and academics. Participants had an opportunity to hear updates on the

regulatory situation in all seven 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.

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.

The Management Committee also considered new work item proposals, and decided on the

international harmonization of the approach to standalone medical device software and on the

definition of common data elements describing medical devices through the regulatory

lifecycle. In response to a new work item proposal, there was also unanimous support on the

importance of involving the medical profession in the IMDRF work. In addition, the

Management Committee approved two work item extensions for the Medical Device Single

Audit Program: the Assessment Program and Auditing Strategy of Medical Device

Recognized Auditing Organizations and the Assessor Competency and Training Requirement

for Regulatory Authorities undertaking assessments of Auditing Organizations.

1

网盘链接

百度网盘：https://pan.baidu.com/s/1xEEDOgdGucoaTk7f8phIKw
提取码：hdpx

【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：23.0316 毫秒

相关评论

相关文章