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GHTF/SG1/N065:2010 GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb)

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GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force发布的GHTF标准，适用于世界。

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GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb)[附网盘链接]
GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices - PDF (106kb)[附网盘链接](截图)

 

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标准部分原文

GHTF/SG1/N065:2010

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 the 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 and its manufacturer conform 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 has been developed to encourage and support global convergence of

regulatory systems. It offers:

• recommendations for the preparation and maintenance of registration and medical

device listing databases by the Regulatory Authority;

• a harmonized definition of, and recommendations for, registration of medical

device manufacturers and/or other parties in the supply chain; and

• a harmonized definition of, and recommendations for, the listing with a

Regulatory Authority of all medical devices placed on the market by those

parties.

This document is intended for use by Regulatory Authorities (RAs) and the parties

responsible for providing registration and listing information to such authorities, and will

provide benefits in establishing, in a consistent way, an economic and effective approach to

the control of medical devices in the interest of public health. It seeks to strike a balance

between the responsibilities of RAs to safeguard the health of their citizens and their

obligations to avoid placing unnecessary burdens upon the industry.

The GHTF supports and encourages regulatory harmonization but recognises that some

RAs may have to reflect different local needs when considering the recommendations in this

guidance document. However, RAs that are developing registration and listing procedures or

amending existing ones are encouraged to consider the adoption of the recommendations

described in this document, as this will help to reduce the diversity of practices worldwide

and facilitate the process of harmonization.

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

italicised for clarity.

August 27, 2010 Page 4 of 12

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