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GHTF/SG1/N071:2012 GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)

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GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于May 16 , 2012发布的GHTF标准，适用于世界。

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GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)[附网盘链接]
GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)[附网盘链接](截图)

 

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Study Group 1 Final Document GHTF/SG1/N071:2012

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 those regulatory means considered the most suitable.

The primary way in which the Global Harmonization Task Force (GHTF) achieves its

goals is through the production of harmonized guidance documents suitable for

implementation or adoption by member Regulatory Authorities, as appropriate taking into

account their existing legal framework, or by nations with developing regulatory

programmes. Eliminating differences between jurisdictions decreases the cost of gaining

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

This guidance document is one of a series that together describe a global regulatory

model for medical devices. It provides a definition of a term that is used in all GHTF

publications. The GHTF first published guidance on this subject in a document entitled

GHTF/SG1/N29:2005 Definition of the Term 'Medical Device'.

This document supersedes that previous version. It has been changed to:

 modify the definition of ‘medical device’;

 provide a definition for the term 'In Vitro Diagnostic (IVD) medical device';

 provide ancillary definitions for 'accessory to a medical device' and ‘accessory

to an IVD medical device’ in Section 4.0 of the document; and

 clarify the ‘Notes’ within the document.

This document is intended for use by Regulatory Authorities, Conformity Assessment

Bodies and industry, 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.

Regulatory Authorities that are developing regulations or amending existing ones are

encouraged to consider the adoption of this guidance and the principles it embodies, as this

will help to reduce the diversity of schemes worldwide and facilitate the process of

harmonization.

This guidance document has been prepared by Study Group 1 of the Global

Harmonization Task Force (GHTF). Comments or questions about it should be directed to

1

the Chair of GHTF Study Group 1 whose contact details are available on the GHTF website .

1

www.ghtf.org

th

May 16 , 2012 Page 4 of 6

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