WHO Medical Device Regulations

 WHO Medical Device Regulations

Global overview and guiding principles

WHO Medical Device Regulations, Global overview and guiding principles, Introduction:  The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities.

Introduction:

The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. For example, legal terms and their meanings are sometimes non-uniform even within one regulatory system. In an attempt to make this complex subject easier to grasp, this Guide presents a common framework that integrates the regulatory systems of the five countries or regions with the most advanced medical device regulations. Non-technical language, graphics, tables and memory anchors are used to present an overview of medical device safety issues and regulatory philosophy.

The Guide begins by explaining how safety is a risk management issue, and how optimum safety and performance require cooperation among all who are involved in the life span of a medical device. The critical elements of medical device regulations are illustrated using a common framework for regulatory development; as well as the current regulatory tools of the Global Harmonization Task Force (GHTF) and all the key documents it has issued in the past three years.

Understanding the different phases in the life span of a medical device and the common framework are first steps to successful harmonization and simplification worldwide.


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Contents

Foreword 

Glossary 

Note on the definition of medical devices 

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 labelled “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 


WHO Medical Device Regulations

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