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GHTF/SG1/N046:2008 GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)

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GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)[附网盘链接]是于July 31, 2008发布的GHTF标准，适用于全球范围。

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GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)[附网盘链接]
GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008 - PDF (87kb)[附网盘链接](截图)

 

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SG1 Final Document GHTF/SG1/N046:2008

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 In Vitro

Diagnostic (IVD) medical devices. The purpose of such guidance is to harmonize the

documentation and procedures that are used to assess whether an IVD 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 should be read in conjunction with the GHTF document on Principles

of In Vitro Diagnostic (IVD) Medical Devices Classification. The linked adoption of

documents on classification and conformity assessment is important to ensure a consistent

approach across all countries/regions adopting the global regulatory model recommended by

the GHTF, so that premarket approval for a particular IVD medical device may become

acceptable globally.

This document has been developed to encourage and support global convergence of

regulatory systems. It 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 IVD medical devices in the interest of

public health. It seeks to strike a balance between the responsibilities of Regulatory

Authorities to safeguard the health of their citizens and their obligations to avoid placing

unnecessary burdens upon the industry. Study Group 1 of the GHTF supports and

encourages regulatory harmonization but recognises that some Regulatory Authorities may

have to reflect different local needs when they introduce new regulations on conformity

assessment. However, Regulatory Authorities that are developing conformity assessment

schemes or amending existing ones are encouraged to consider the adoption of the system

described in this document, as this will help to reduce the diversity of schemes world-wide

and facilitate the process of harmonization.

At this time, conformity assessment requirements and other regulatory controls

assigned to each risk class of IVD medical devices by different Regulatory Authorities have

yet to be harmonized and may vary from the guidance provided in this document.

Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this

guidance document. Comments or questions about it should be directed to either the

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

1

GHTF web page .

1

www.ghtf.org

February 26, 2008 Page 4 of 15

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