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GHTF/SG1/N78:2012 GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb)

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GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于November 2 , 2012发布的GHTF标准，适用于全球范围。

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GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb)[附网盘链接]
GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012 - PDF (382kb)[附网盘链接](截图)

 

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SG1 Final Document GHTF/SG1/N78:2012

1.0 Introduction

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 has been developed to encourage and support global convergence of

regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity

Assessment Bodies (CABs) 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. 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 regulated industry.

This document should be read in conjunction with the GHTF document entitled

Principles of Medical Devices Classification that prescribes rules to separate medical devices

into four groups or classes where Class A are the least hazardous and Class D the most

hazardous. The link between device classification and conformity assessment is fundamental

to the development of an effective global regulatory model. If both are adopted in a

consistent manner, the goal of a premarket approval for a particular device being accepted

globally may be achieved.

This document supersedes GHTF/SG1/N40:2006 which provided guidance on the

same topic.

Where other guidance documents within the series are referenced within this text,

their titles are italicised for clarity.

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 Chair or

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

1

website .

2.0 Rationale, Purpose and Scope

2.1 Rationale

Conformity assessment, conducted before and after a medical device is placed on the

market, and post-market surveillance of devices in actual use are complementary elements of

the GHTF global regulatory model. They are intended to provide the objective evidence of

safety, performance, and benefits and risks to maintain public confidence.

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www.ghtf.org

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November 2 , 2012 Page 4 of 17

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