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IMDRF/MC/N2FINAL:2021 (Edition 7) IMDRF Standard Operating Procedures - PDF (416kb)

赵静曼 3/7/2022 浏览 183 IMDRF/MC/N2 全球

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IMDRF Standard Operating Procedures - PDF (416kb)[附网盘链接]是IMDRF Management Committee发布的GHTF标准，适用于全球。

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IMDRF Standard Operating Procedures - PDF (416kb)[附网盘链接]
IMDRF Standard Operating Procedures - PDF (416kb)[附网盘链接](截图)

 

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IMDRF/MC/N2FINAL:2021 (Edition 7)

___________________________________________________________________________________________

1.0 Introduction

This document is intended to describe the basic procedures that the International Medical Device

Regulators Forum (IMDRF) follows when revising the membership of the Management

Committee, establishing Subcommittees or Working Groups, developing IMDRF Documents or

managing documents developed under the Global Harmonization Task Force (GHTF).

The Operating Procedures outlined in this document, in conjunction with the Terms of Reference,

are designed to be flexible so that should the need arise, the IMDRF can respond to challenges

with respect to its objectives in a timely manner.

2.0 IMDRF Membership

IMDRF membership criteria, roles, and responsibilities are listed in each of the Sections below

and are also outlined in Annex D.

2.1 Management Committee

The Management Committee consists of regulatory authorities and is responsible for the oversight

and decision making for all IMDRF activities. Management Committee members are voting

members and are expected to attend all IMDRF Management Committee meetings which are held

face to face or by teleconference as well as to ensure regular contribution to IMDRF activities and

participate in at least 2/3 of the IMDRF Working Groups. Management Committee members have

two (2) representatives per delegation and these representatives need to be knowledgeable on

IMDRF matters. It is expected that these representatives would consistently attend subsequent

IMDRF meetings and that any changes to representatives would require notification to the IMDRF

Management Committee chair.

In reviewing application requests for membership, the Management Committee will consider

whether the regulatory authority has met each of the following requirements, including having:

 been a regional influence,

 participated in all IMDRF MC meetings (including teleconferences) for the last two (2)

consecutive years,

 participated in a majority of Working Groups as an Official Observer for the last two (2)

consecutive years, providing active contribution, and

 been an Official Observer for at least the last two (2) consecutive years prior to the

application for membership, and

 sufficient capacity to chair the MC and provide the Secretariat for a year, including hosting

two (2) face to face meetings and two (2) scheduled teleconferences.

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