Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

655 Pages·2018·14.56 MB·English

by  Jack Wong

Handbook of Medical Device
Regulatory Affairs in Asia

Handbook of Medical Device
Regulatory Affairs in Asia
Second Edition
edited by
Jack Wong
Raymond K. Y. Tong
Published by
Pan Stanford Publishing Pte. Ltd.
Penthouse Level, Suntec Tower 3
8 Temasek Boulevard
Singapore 038988

Email: [email protected]
Web: www.panstanford.com
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library.
Handbook of Medical Device Regulatory Affairs in Asia (Second
Edition)
CAollp riygrhigtsh rte ©se r2v0e1d8. T Phains bSotoank,f oorr dp aPrutsb tlhisehrienogf ,P mtea.y L ntodt. be reproduced in any
form or by any means, electronic or mechanical, including photocopying,
recording or any information storage and retrieval system now known or
to be invented, without written permission from the publisher.
For photocopying of material in this volume, please pay a copying fee
through the Copyright Clearance Center, Inc., 222 Rosewood Drive,
Danvers, MA 01923, USA. In this case permission to photocopy is not
required from the publisher.
ISBN 978-981-4774-31-4 (Hardcover)
ISBN 978-0-429-50439-6 (eBook)
Contents
Preface
xxxiii
1. How to Train University Students in Regulatory Affairs 1
Raymond K. Y. Tong
1.1 Introduction 1
1.2 A Sample of Regulatory Affairs Exercises for
Students 2
1.2.1 Background 2
1.2.2 LifPealorntg 1 L:e aInrntirnogd uction 4
2. The Evolution of the Regulatory Professional: Perspectives
on the Skill Sets and Capabilities That Will Define the Next
Generation of Regulatory Professionals 7
David Martin and Neil Lesser
2.1 Introduction 7
2.2 Drivers of Change 8
2.3 Historical Role and Skill Set of a Regulatory
Professional 10
2.4 Changing Role and Skill Set of the Regulatory
Professional 12
2.5 Develop as a Center of Intelligence 12
2.6 Advance toward Strategic Relationship
Management 13
2.7 Develop as a Strategic Business Partner 13
3. 2Th.8e RoCleo nocf ltuhseio Ans: iWa Rheagt uWlailtlo Irty T Aakffea itros GTeeta Tmh einr eR?e lation 14
to the Commercial Team and Other Departments 17
Fredrik Dalborg
3.1 Introduction 17
vi Contents
3.2 Key Trends in the Asia Medical Device Industry 18
3.3 The Role of the Asia RA Team in a Global Medical
Device Organization 19
3.4 Coordination between Commercial Teams and
RA Teams 20
3.5 The Role of the RA Team during the Different
Stages of a Product Life 21
3.5.1 Product Development 21
3.5.2 Market Introduction 21
3.5.3 Product Maintenance 22
3.5.4 Product Phase-Out 22
3.6 The RA Professional: A Trusted Advisor 23
4. C3.o7m meSrucmiaml Saerny se and What It Means for a Regulatory 24
Manager or Executive 25
Annie Joseph
4.1 Know the Basics 26
4.1.1 Marketing or Commercial Plan 26
4.1.2 Priority Products and How They Are
Ranked in the Company 27
4.1.3 Know Your Commercial People 27
4.2 Maintain a Healthy Communication 27
4.3 Be Proactive and Part of the Solution 27
4.4 Remain the Expert and Provide Clarity to the
Organization 29
5. M4.5e dicaBl eD ae vCihcaem Rpeigounl afotor rNy eSwtr aPtreogdyu:c Pt rLoaduunccth es 29
Development and Product Registration in Asia and
Globally 35
May Ng, Martin Ng, Ray Soh, Fadzlon Yunos, and Stephen Hsu
5.1 Introduction 35
5.2 Information in Regulatory Strategy 36
5.2.1 Device Name 36
5.2.2 Device Description 37
Contents vii
5.2.3 Intended Use 37
5.2.4 Country of Interest 38
5.2.5 Device Classification 38
5.2.6 Product Registration or Conformity
Assessment Route and Its Approval
Timeline 39
5.2.7 Technical Documentation Requirement 39
5.2.8 Quality Management System Requirement 39
5.2.9 Clinical Assessment 40
5.2.10 Reimbursement Assessment 40
6. 5R.3e gulaCtoornyc lAuffsiaoirns as a Business Partner 4403
Claudette Joyce C. Perilla
7. Introduction to Regulatory Affairs Professionals’ Roles 47
Dacia Su
8. What It Means to Be a Medtech Regulatory Journalist 51
Amanda Maxwell
9. Affordable Access to Medical Devices in Developing
Countries 57
Rosanna W. Peeling and Tikki Pang
9.1 Introduction 57
9.2 Why Is Affordable Access to Medical Devices
Important for Developing Countries? 58
9.2.1 Emergency Preparedness 59
9.2.2 Efficiency and Effectiveness of Health
Systems 59
9.2.3 Health Equity 60
9.3 Case Studies 61
9.3.1 Delay in Eligibility to Treatment for HIV 61
9.3.2 Delay in Access to Early Diagnosis of
Tuberculosis 62
9.3.3 Misleading Claims of Test Performance
for Dengue Rapid Tests 62
viii Contents
9.3.4 Case Study—Access versus Performance:
Basis for FDA Approval of the First
Over-the-Counter Rapid HIV Test in the
United States 63
9.3.4.1 Background 63
9.3.4.2 Performance expectations 63
9.3.4.3 Risk benefit analysis 64
10. R9.e4g ulaTtohrey W Spaeyc Fiaolriswtsa rind Medical Devices in Europe: 65
Meeting the Challenge of Keeping Current in a Changing
Environment—How TOPRA Supports Professionals in a
Dynamic Industry 69
Lynda J. Wight
10.1 The European MedTech Environment 69
10.2 What Is TOPRA? 71
10.3 Why Be a TOPRA Member? 71
10.4 What Support Is Offered? 72
10.4.1 Competency Frameworks 72
10.4.2 Training and Development 73
10.4.3 Education 74
10.4.4 Networks and Collaborations 75
10.4.5 Information 75
Pa1r0t. 52 : MLeodoikcianlg Dtoe vthicee F Suatufreet y and Related ISO Standards75
11. Biomedical Devices: Overview 79
Piu Wong
11.1 Historic Aspect of Medical Devices 79
11.2 Biomedical Market Environment 81
11.3 Orthopedics 82
11.3.1 Market 82
11.3.2 Materials 83
11.3.3 Biocompatibility 83
Contents ix
11.3.4 Fabrication 84
11.3.5 Polyethylene Fabrication 84
11.4 Vision Care 86
11.4.1 Market 86
11.4.2 Diagnostic Devices 86
11.4.3 Treatment 87
11.5 Diabetics 88
11.6 Obesity 88
11.7 Vascular Disease 88
12. 1La1b.8e linCgo, nLcalbuedli,n agn Rde Lmanargkusa ge: A Truly Global Matter 8993
Evangeline D. Loh and Jaap L. Laufer
12.1 Introduction 93
12.2 Definition of Labeling 95
12.3 Elements of Labeling 97
12.4 Risk Management, Clinical Evaluation and
Labeling: The Core Triangle for Safe and Effective
Use of the Device 99
12.5 Labeling and Promotion 101
12.6 e-Labeling, Web Sites, Internet, and Social Media:
A Brave New World for Labeling 101
12.7 Language, Language Level, and Intended User 103
13. 1R2e.g8u laCtoornyc lAufsfiaoinrs for Medical Device Clinical Trials 105
in Asia Pacific 107
Seow Li-Ping Geraldine
13.1 Introduction 107
13.2 Medical Device Clinical Trials versus
Pharmaceutical Clinical Trials 108
13.3 Regulation of Clinical Trials 111
13.4 Country Regulations 117
13.4.1 Australia 117
13.4.2 China 119