Handbook of Medical Device Regulatory Affairs in Asia

610 Pages·2013·13.48 MB·English

by  Jack Wong

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CRC Press
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Contents
Preface
Asia Regulatory Professional Association
xxxi
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 BackgrPoaurntd 1 Introduction 2
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
2.8 Conclusion: What Will It Take to Get There? 14
vi Contents
3. Ensuring Smooth Product Launch: Regulatory Interfaces
with Marketing and Supply Chain 17
Alok Mishra
3.1 Introduction 17
3.2 New Product Pipeline 18
3.3 Planned Launch Dates 18
3.4 New Product Forecasts 19
4. What Is the Right Thing to Do? 21
3.5 New Product Approval Dates 19
Jack Wong
4.1 Right Job 21
4.2 Two Key Challenges in Our Job 22
4.2.1 Quality 22
4.2.2 Speed 22
4.3 Regulatory Affairs Job Is a Combination of Science,
Legal Affairs, and Moral 22
5. Affordable Access to Medical Devices in Developing
4.4 Persons versus Things 22
Countries 25
Rosanna W. Peeling and Tikki Pang
5.1 Introduction 25
5.2 Why Is Affordable Access to Medical Devices
Important for Developing Countries? 26
5.2.1 Emergency Preparedness 27
5.2.2 Efficiency and Effectiveness of Health Systems 27
5.2.3 Health Equity 28
5.3 Case Studies 29
5.3.1 Delay in Eligibility to Treatment for HIV 29
5.3.2 Delay in Access to Early Diagnosis of
Tuberculosis 29
5.3.3 Misleading Claims of Test Performance for
Dengue Rapid Tests 30
5.3.4 Case Study — Access versus Performance: Basis
for FDA Approval of the First Over-the-Counter
Rapid HIV Test in the United States 31
Contents vii
5.3.4.1 Background 31
5.3.4.2 Performance expectations 31
5.3.4.3 Risk bene(cid:2)it analysis 32
5.4 The Way Forward 33
6. A Story of Attention to Detail 35
Richard Liu
P(cid:2)(cid:3)(cid:4) 2 M(cid:5)(cid:6)(cid:7)(cid:8)(cid:2)(cid:9) D(cid:5)(cid:10)(cid:7)(cid:8)(cid:5) S(cid:2)(cid:11)(cid:5)(cid:4)(cid:12) (cid:2)(cid:13)(cid:6) R(cid:5)(cid:9)(cid:2)(cid:4)(cid:5)(cid:6) ISO S(cid:4)(cid:2)(cid:13)(cid:6)(cid:2)(cid:3)(cid:6)(cid:14)
7. Biomedical Devices: Overview 39
Piu Wong
7.1 Historic Aspect of Medical Devices 39
7.2 Biomedical Market Environment 41
7.3 Orthopedics 42
7.3.1 Market 42
7.3.2 Materials 43
7.3.3 Biocompatibility 43
7.3.4 Fabrication 44
7.3.5 Polyethylene Fabrication 44
7.4 Vision Care 46
7.4.1 Market 46
7.4.2 Diagnostic Devices 46
7.4.3 Treatment 47
7.5 Diabetics 48
7.6 Obesity 48
7.7 Vascular Disease 48
7.8 Concluding Remarks 49
8. Labeling, Label, and Language: A Truly Global Matter 53
Evangeline D. Loh and Jaap L. Laufer
8.1 Introduction 53
8.2 De(cid:2)inition of Labeling 55
8.3 Elements of Labeling 56
8.4 Risk Management, Clinical Evaluation and Labeling:
The Core Triangle for Safe and Effective Use of
the Device 59
8.5 Labeling and Promotion 60
viii Contents
8.6 e-Labelling, Web Sites, Internet, and Social Media:
A Brave New World for Labeling 61
8.7 Language, Language Level and Intended User 63
9. Clinical Trials: Legal and Ethical Considerations of
8.8 Conclusion 64
Increasing Globalization 67
Paula Celine Trepman
9.1 Introduction 67
9.2 The Increasing Trend of Offshore Clinical Trials 68
9.3 International Standards to Protect Patients 69
9.4 Breaches of Clinical Trial Legality 70
9.5 Issues of Informed Consent 71
9.6 Cultural and Social Factors 71
9.7 Vulnerable Patient Populations 72
9.8 Economic Considerations 72
9.9 Comparison of Trial Population to Target
Population 73
10. Regulatory Affairs for Medical Device Clinical Trials in
9.10 Conclusion 75
Asia Pacific 79
Seow Li-Ping Geraldine
10.1 Introduction 79
10.2 Medical Device Clinical Trials versus
Pharmaceutical Clinical Trials 80
10.3 Regulation of Clinical Trials 83
10.4 Country Regulations 87
10.4.1 Australia 89
10.4.2 China 91
10.4.3 Hong Kong 91
10.4.4 India 91
10.4.5 Malaysia 92
10.4.6 New Zealand 92
10.4.7 Singapore 93
10.4.8 South Korea 94
Contents ix
10.4.9 Taiwan 95
10.4.10 Thailand 96
11. Medical Device Classification Guide 101
10.5 Moving Ahead as Regulatory Affairs Professionals 96
Patricia Teysseyre
11.1 How to Carry Out Medical Device Classification 101
11.1.1 Scope 101
11.1.2 Definitions 102
11.2 Main Classifications 103
11.2.1 Medical Devices 103
11.2.2 Active Devices 103
11.2.3 IVD Devices 104
11.2.4 IVD Case Study 106
11.2.4.1 US FDA 107
11.2.4.2 Canada 107
11.2.4.3 EU 108
11.2.4.4 Singapore 109
11.3 Medical Device Classification: Practical
12. ISO 13485:2003 Medical Devices — Quality Management
Examples 109
Systems — Requirements or Regulatory Purposes 125
Ann Goodall and Gert Bos
12.1 Introduction 125
12.2 Background and Origins of ISO 13485:2003 126
12.3 Management Systems Standard 128
12.4 Quality Management Systems 129
12.5 ISO 9000 and ISO 13485 Quality Management
System Family of Standards 130
12.6 ISO 13485:2003 and Regulatory Requirements
Around the World 131
12.7 Good Reasons to Implement an ISO 13485:2003
Quality Management System 132
12.8 Process Approach 132
12.9 Planning the Implementation 133