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GHTF/SC/N1R8:2005 GHTF Guiding Principles - PDF (490kb)

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标准简介

GHTF Guiding Principles - PDF (490kb)[附网盘链接]由GHTF Steering Committee于May 20, 2005发布，适用于全球。

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GHTF Guiding Principles - PDF (490kb)[附网盘链接]
GHTF Guiding Principles - PDF (490kb)[附网盘链接](截图)

 

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标准部分原文

GHTF Steering Committee Final Document GHTF/SC/N1R8:2005

1.0 Introduction

The guiding principles outlined in this do cument, in conjunction with the “GHTF Roles and

Responsibilities” 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 Goals and Objectives

2.1. Goals

The goal of the Global Harmonization Task Force is to provide a collaborative forum for representatives

of member national regulatory authorities and industry representatives to promote internationa l

convergence in regulatory requirements and practices, in particular to:

• promote the safety, effectiveness/ performance and quality of medical devices,

• encourage technological innovation,

• foster international trade,

• serve as an information exchange fo rum through which countries with medical device regulatory

systems under development can benefit from the experience of those with established systems

and/or pattern their practices upon those of GHTF documents,

Notwithstanding the above, it is recognized that participating regulatory authorities retain the right to

regulate according to their applicable sovereign regulations .

2.2. Objectives

To achieve the above goals the objectives of GHTF are:

(A) to encourage the development of a harmonized regulatory environment, allowing for better

protection of public health, and thereby facilitating the availability of medical technologies

consistent with the state o f the art and current knowledge,

(B) the development of guidance documents and recommended pr ocedures in order to work towards

convergence of the medical device regulatory systems of its Members within the boundaries of

their legal and institutional constraints ,

(C) to define common elements of the regulatory systems of its Members and to work towards a

coherent implementation of these elements, to encourage the development of related common

data sets and their acceptance by regulatory authorities with the aim of avoiding duplication of

files,

(D) to facilitate the development of an internati onal post-market and vigilance system that will reduce

the likelihood of repeated adverse events and influence the development of new medical devices,

May 20, 2005 Page 4 of 7

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