A simple guide to understanding medical device regulations

Shalinee Naidoo

• Publisher: Arcler Press
• Year: 2020
• eBook ISBN: 9781774078235
• Topic: Technology & Engineering
• Subtopic: Materials Science
• Index: Technology & Engineering

As innovation and rapid advancement in technologies take over, medical devices have now become one of the fastest-growing industries globally. In 2000, it was estimated that one and half million different medical devices were available on the market worldwide. For many countries, their regulatory systems have proven to be ineffective in quality management and in monitoring the domestic market to prevent unsafe and low-quality medical products from entering. The lack of harmonized processes when assessing the safety and efficacy or performance of medical products has also led to an increase in costs associated with licensing where required. Regulatory controls for medical devices are often complicated to implement due to the many different types of devices available on the market. Often the risks associated with each type of device differ, making the opportunity for misuse considerable. The purpose of this book is to provide readers with an overview of how regulatory systems work and what goes into implementing a simple regulatory framework. It also aims to highlight the importance of long-lasting good governance where regulation of medical devices is concerned and to provide a step-by-step approach on the development of national regulatory programs for medical devices. It looks at what are some of the guiding principles and essential features of a simple medical device regulatory program, what governs the safety of medical devices and who is responsible for implementation, applying conformity assessment rules and the use of standards to guide a regulatory model.

Table of contents

• Cover
• Title Page
• Copyright
• ABOUT THE AUTHOR
• TABLE OF CONTENTS
• Glossary
• List of Figures
• List of Tables
• List of Boxes
• List of Abbreviations
• Preface
• Chapter 1 Introduction
• Chapter 2 What is a Medical Device?
• Chapter 3 Classification of Medical Devices
• Chapter 4 History of Medical Device Regulations
• Chapter 5 Understanding the 2001 Model Regulatory Program for Medical Devices as Laid Out By WHO
• Chapter 6 Safety of Medical Devices
• Chapter 7 Assessing The Effectiveness/Performance Of Medical Devices
• Chapter 8 Conformity Assessments of Medical Devices
• Chapter 9 Understanding Sted (Summary Technical Documentation)
• Chapter 10 Standards
• Chapter 11 The Global Harmonized Task Force
• Chapter 12 Nomenclature Of Medical Devices
• Chapter 13 International Medical Devices Regulators Forum (IMDRF)
• Chapter 14 Design and Implementation of National Medical Device Regulatory Systems
• Chapter 15 Why Are Regulatory Controls for Medical Devices So Complicated?
• Chapter 16 Ensuring Safety of Medical Devices
• Chapter 17 Phases in the Life Span of Medical Devices
• Chapter 18 Who Is Responsible for Ensuring the Safety of Medical Devices?
• Chapter 19 Understanding the Role of Each Participant/Stakeholder in Medical Device Safety
• Chapter 20 Shared Responsibilities for Safety and Performance of Medical Devices
• Chapter 21 Understanding the Stages of Regulatory Control
• Chapter 22 General Development Phases of National Regulatory Authorities
• Chapter 23 Responsibilities of National Regulatory Authorities
• Chapter 24 Principles of Good Regulatory Practice
• Chapter 25 A Simple Guide to Regulating Medical Devices
• Chapter 26 Optimizing the Use of Regulatory Resources
• Chapter 27 How to Increase Knowledge of the Medical Device Sector
• Chapter 28 How to Establish a Basic Regulatory Program
• Chapter 29 How to Draft a Comprehensive Policy/Guideline on Medical Device Management
• Chapter 30 Post Market Surveillance
• Chapter 31 Setting Priorities for Regulatory Programme Development
• Conclusion
• Bibliography
• Index
• Back Cover