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GHTF/SG1/N055: 2009 GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)

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GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)[附网盘链接]是于March 26, 2009发布的GHTF标准，适用于世界范围。

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GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)[附网盘链接]
GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)[附网盘链接](截图)

 

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标准部分原文

GHTF/SG1/N055:2009

1.0 Introduction

The objective of the Global Harmonization Task Force (GHTF) is to encourage

convergence at the global level in the evolution of regulatory systems for medical devices in

order to facilitate trade whilst preserving the right of participating members to address the

protection of public health by regulatory means considered to be most suitable.

The primary way in which the GHTF achieves its goals is through the production of a

series of guidance documents that together describe a global regulatory model for medical

devices. The purpose of such guidance is to harmonize the documentation and procedures

that are used to assess whether a medical device conforms to the regulations that apply in

each jurisdiction. Eliminating differences between jurisdictions decreases the cost of gaining

regulatory compliance and allows patients earlier access to new technologies and treatments.

This document offers guidance to Regulatory Authorities, Conformity Assessment

Bodies and industry. It has been developed to encourage and support global convergence of

regulatory systems by offering definitions for the terms “manufacturer”, “authorised

representative”, “distributor” and “importer”. Regulatory Authorities developing such

definitions or amending existing ones are encouraged to consider the adoption of those in this

document, as this will help reduce the diversity of terminology worldwide and facilitate the

process of harmonization.

Where another GHTF guidance document is referenced within this text, its title is

italicised for clarity.

This document was developed by GHTF Study Group 1 in collaboration with GHTF

Study Groups 2, 3 and 4. Comments or questions about this document should be directed to

either the Chairman or Secretary of GHTF Study Group 1 whose contact details may be

1

found on the GHTF web page .

2.0 Rationale, Purpose and Scope

2.1 Rationale

The term “manufacturer” appears in many GHTF documents and is associated with

various obligations and responsibilities. The development of a consistent, harmonized

definition for a ”manufacturer” would support global convergence of regulatory systems and

offer significant benefits to Regulatory Authorities and the organisations responsible for

making and/or placing medical devices onto the market. Harmonization of the terms

“authorised representative”, “distributor” and “importer” would be of benefit, too.

Harmonization should improve consistency and the transparency of regulatory

controls. Eliminating differences between jurisdictions decreases the cost of gaining

regulatory compliance and allows patients earlier access to new technologies and treatments.

1

www.ghtf.org

March 26, 2009 Page 4 of 7

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