Medical device regulations : global overview and guiding principles.

Format:

Book

Government document

Author/Creator:

Cheng, Michael.

Contributor:

World Health Organization, Contributor.

Language:

English

Subjects (All):

Medical instruments and apparatus--Standards.

Medical instruments and apparatus.

Biomedical materials--Standards.

Biomedical materials.

Physical Description:

ix, 55 p. : ill.

Edition:

1st ed.

Place of Publication:

Geneva : World Health Organization, c2003.

Language Note:

English

Summary:

Medical devices and equipment are a vital component of patient care. From a simple tongue depressor to a sophisticated haemodialysis machine, medical devices are needed at every level of the health service. Yet many health services continue to lack information and financial resources to acquire the devices they really need, i.e. those that will address the specific disease burden in their country. Effective implementation of a National Regulatory Authority is a first step towards the cost-effective management of medical devices that meet international quality and safety standards, throughout their entire life span, from conception to disposal. This publication offers countries a framework within which they can plan - or improve - their regulatory system for medical devices. Governments are particularly encouraged to take advantage of the extensive work undertaken over the last ten years by national and regional bodies to harmonize regulations on medical devices. Countries can also adopt the device approvals of the advanced regulatory systems. These two approaches alone can enable national health authorities to redirect scarce resources towards locally-assessed needs, such as vendor and device registration, training, surveillance and information exchange systems on medical devices in use.

Contents:

Intro

Contents

Foreword

Glossary

Chapter 1. Introduction

Chapter 2. Medical device safety

2.1 Medical device safety and risk management

2.2 Effectiveness/performance of medical devices

2.3 Phases in the life span of a medical device

2.4 Participants in ensuring the safety of medical devices

2.5 The role of each participant/stakeholder

2.6 Shared responsibility for medical device safety and performance

Chapter 3. Governmental regulation of medical devices

3.1 Critical elements for regulatory attention

3.2 Stages of regulatory control

3.3 A common framework for medical device regulations

3.4 Regulatory tools and general requirements

3.4.1 Product control

3.4.2 Vendor establishment control

3.4.3 Post-market surveillance/vigilance

3.4.4 Quality system requirements

Chapter 4. Global Harmonization Task Force (GHTF)

4.1 Objectives

4.2 Scope of the four GHTF study groups

4.3 Benefits of the GHTF

4.4 Final documents from the GHTF

4.5 Global Medical Device Nomenclature (GMDN)

Chapter 5. Standards

5.1 What are standards?

5.2 Why do we need standards?

5.3 Voluntary and mandatory standards

5.4 Standards development process

5.5 Conformity assessment with standards

5.6 National and international standards systems

5.7 Identification of standards

5.8 Current trends in the use of standards in medical device regulations

Chapter 6. Optimizing the use of regulatory resources

6.1 Increasing knowledge of the medical device sector

6.2 Establishing basic regulatory programmes

6.2.1 Basic legislation

6.2.2 Sharing problem reports

6.3 Drafting a comprehensive policy or guideline on medical device management

6.3.1 Advantages of a national policy

6.3.2 Classification of medical devices

6.3.3 Medical device product control.

6.3.4 Product representation control

6.3.5 Vendor establishment control

6.3.6 The control of home-use, refurbished, and donated devices

6.3.7 The re-use of medical devices that are labeled "for single use

6.3.8 Post-market surveillance

6.3.9 Recognition and use of established national or international standards

6.4 Promoting compliance and cooperation

6.5 Setting priorities for regulatory programme development

6.6 Cautions in interpreting medical device "export certificates

Chapter 7. Priorities on the international agenda

Annex 1. Resources for medical device information

Annex 2. Final documents of the GHTF as they relate to the Common Regulatory Framework

Annex 3. Relationship between ISO9001:1994 and ISO13485:1996

Annex 4. Aide-mémoire for National Medical Device Administrations.

Notes:

"Prepared under the principle authorship of Dr Michael Cheng"--T.p. verso.

Includes bibliographical references.

ISBN:

1-280-06057-3

92-4-068095-0

9786610060573

OCLC:

55663725