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GHTF GHTF SG1 Principles of Medical Devices Classification - November 2012 - PDF (772kb)

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Study Group 1 Final Document GHTF/SG1/N77:2012

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 Conformity Assessment for Medical Devices that prescribes conformity

assessment requirements appropriate to each of the four classes proposed herein. The link

between device classification and conformity assessment is fundamental to the development of

an effective global regulatory model. If such is adopted in a consistent manner by all

jurisdictions, the goal of a premarket approval for a particular device being accepted globally,

may be achieved.

This document supersedes GHTF/SG1/N15:2006 which provided guidance on the

same topic. It has been modified to:

• clarify the basis of allocating medical devices to one of four classes;

• change the rule applying to sterilisation and disinfection devices;

• remove the inconsistency with GHTF/SG1/N011 Summary Technical

Documentation for Demonstrating Conformity to the Essential Principles of

Safety and Performance of Medical Devices (STED);

• add a Section on the reclassification of medical devices; and

• incorporate changes resulting from the public scrutiny process.

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

1

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

1

www.ghtf.org

nd

November 2 , 2012 Page 4 of 30

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