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GHTF/SC/N2R12:2010 GHTF Roles and Responsibilities - PDF (168KB)

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标准简介

GHTF Roles and Responsibilities - PDF (168KB)[附网盘链接]由GHTF Steering Committee于21 April 2010发布，适用于全球。

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GHTF Roles and Responsibilities - PDF (168KB)[附网盘链接]
GHTF Roles and Responsibilities - PDF (168KB)[附网盘链接](截图)

 

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标准部分原文

GHTF Steering Committee Final Document GHTF/SC-N2R12:2010

1.0 Introduction

This document is intended to facilitate the management of GHTF activities by adequately describing the

roles and responsibilities of all those involved in GHTF work.

This document establishes the different membership categories and the governing procedures for the

components of GHTF.

The roles and responsibilities outlined in this document, in conjunction with the “GHTF Guiding

Principles” and “GHTF Operating Procedures” and the “GHTF Strategic Directions”, are designed to be

flexible, so that should the need arise, the GHTF can respond to challenges with respect to its objectives

in a timely manner.

2.0 Membership

GHTF was established as a voluntary international group of medical device regulatory authorities, and

medical device trade associations from Europe, the United States of America (USA), Canada, Japan and

Australia, grouped into three geographical areas, namely Europe, North America and Asia-Pacific. For

this purpose Europe means the European Union, and its candidate and associated countries, and countries

of the European Free Trade Association (EFTA).

Participation in GHTF’s work takes place under different categories of membership – Founding

Members, Regional Members, Participating Members, and Liaison Bodies.

2.1 Founding Members

Founding Members are regulatory authorities or industry representatives from Europe, the United States

of America (USA), Canada, Japan and Australia. These Founding Members created GHTF and have well

established regulatory systems, allowing for technological innovation whilst promoting a high level of

safety and effectiveness/performance.

Founding Members will take appropriate steps to implement GHTF guidance and policies within the

boundaries of their legal and institutional constraints. Regulatory authorities agree to promote the GHTF

documents within their own jurisdictions and, in the course of time, seek convergence of regulatory

practices. Regulators hold the ultimate responsibility for this implementation.

Founding Members participate in the Steering Committee, may propose participants for GHTF Study

Groups or Ad Hoc Working Groups, and take part in all GHTF activities, such as plenary meetings,

special topic sessions, regional meetings and GHTF training.

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