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Medical Regulatory Affairs
Medical Regulatory Affairs

An International Handbook for Medical Devices
and Healthcare Products
Third Edition
edited by
Jack Wong
Raymond K. Y. Tong
Published by
Jenny Stanford Publishing Pte. Ltd.
Level 34, Centennial Tower
3 Temasek Avenue
Singapore 039190
Email: editorial@jennystanford.com
Web: www.jennystanford.com
British Library Cataloguing-in-Publication Data

A catalogue record for this book is available from the British Library.
Medical Regulatory Affairs: An International Handbook for Medical

Devices and Healthcare Products (Third Edition)
Copyright © 2022 Jenny Stanford Publishing Pte. Ltd.
All rights reserved. This book, or parts thereof, may not 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 978-981-4877-86-2 (Hardcover)

ISBN 978-1-003-20769-6 (eBook)
Contents
Preface xxxvii
1. How to Train University Students in Regulatory Affairs

to Face the Medical Devices Market Growth after the
COVID-19 Impact 1
Raymond K. Y. Tong
1.1 Introduction 1
1.2 A Sample of Regulatory Affairs Exercises for
Students 3
1.2.1 Background 3
1.2.2 Lifelong Learning 5
Part 1: Introduction
2. The Evolution of the Regulatory Professional:
Perspectives on the Skill Sets and Capabilities That
Will Define the Next Generation of Regulatory
Professionals 9
David Martin and Neil Lesser
2.1 Introduction 9
2.2 Drivers of Change 10
2.3 Historical Role and Skill Set of a Regulatory
Professional 12
2.4 Changing Role and Skill Set of the Regulatory
Professional 14
2.5 Develop as a Center of Intelligence 14
2.6 Advance Toward Strategic Relationship
Management 15
2.7 Develop as a Strategic Business Partner 15
2.8 Conclusion: What Will It Take to Get There? 16
vi Contents
3. The Role of the Asia Regulatory Affairs Team in Relation

to the Commercial Team and Other Departments 19
Fredrik Dalborg
3.1 Introduction 19
3.2 Key Trends in the Asia Medical Device Industry 20
3.3 The Role of the Asia RA Team in a Global Medical
Device Organization 21
3.4 Coordination between Commercial Teams and
RA Teams 22
3.5 The Role of the RA Team during the Different
Stages of a Product Life 23
3.5.1 Product Development 23
3.5.2 Market Introduction 23
3.5.3 Product Maintenance 24
3.5.4 Product Phase-Out 24
3.6 The RA Professional: A Trusted Advisor 25
3.7 Summary 26
4. Commercial Sense and What It Means for a Regulatory

Manager or Executive 27
Annie Joseph
4.1 Know the Basics 28

4.1.1 Marketing or Commercial Plan 28
4.1.2 Priority Products and How They Are
Ranked in the Company 29
4.1.3 Know Your Commercial People 29
4.2 Maintain a Healthy Communication 29
4.3 Be Proactive and Part of the Solution 29
4.4 Remain the Expert and Provide Clarity to the
Organization 31
4.5 Be a Champion for New Product Launches 31
5. Market Strategic Challenges for Medical Device

(Asia/Pacific) 37
Sherwin Tan, Ki Eunyu, Kyser Tay, and David Lee
5.1 Strategic Changes 38

Contents vii
5.1.1 Product Design and Innovation 38

5.1.2 Technological Advancement 38
5.1.3 Distribution Channels 39
5.1.4 Geo-Political Changes 40
5.1.5 Environmental and Health Pandemic 40
5.1.6 Marketing Strategy and Tactics 41
5.2 Strategic Framework 41
5.2.1 Market Analysis and Evaluation 42
5.2.2 Competitive Advantage(s) 43
5.2.3 Scope of Your Products and Markets 43
5.2.4 Decide on Your Resources and Focus
on Them 44
5.2.5 Identify Changes, Prioritize and
Implement Changes 44
5.2.6 Continuously Monitor Performance
and Review Strategy 45
5.3 Key Issues in the Market 45
5.3.1 Internal Organizational Pressures 45
5.3.2 Increasing International Competition 46
5.3.3 Fast-Paced Innovations 46
5.3.4 Organizational Restructuring and
Merger and Acquisition 47
5.3.5 Increased Quality Consciousness 47
5.4 Challenges Suppliers Are Facing 48
5.4.1 Accessing Data across Platforms 48
5.4.2 Identifying Customers across Channels 48
5.4.3 Mapping the Entire Customer Journey 49
5.4.4 Identifying New Potential Customers 49
5.4.5 Maintaining a Consistent Customer
Experience 49
5.4.6 Maintaining Trust and Privacy 50
5.5 Six Growth Challenges 50
5.5.1 Cash Flow Management 50
5.5.2 Responding to Competition 51
5.5.3 Nurturing a Great Company Culture 51
viii Contents
5.5.4 Learning When to Delegate and When

to Get It Done 52
5.5.5 Keeping Up with Market Changes 52
5.5.6 Deciding When to Abandon a Strategy 53
5.6 Five Common Strategic Mistakes 53
5.6.1 Poor Goal Setting 53
5.6.2 Lack of Alignment 54
5.6.3 People Not Being Connected to
Common Goal 54
5.6.4 Failure to Track Progress 54
5.6.5 Not Utilizing Data Analytics 55
6. Regulatory Affairs as a Business Partner 59

Claudette Joyce C. Perilla
7. Introduction to Regulatory Affairs Professionals’ Roles 63

Dacia Su
8. What It Means to Be a Medtech Regulatory Journalist 67

Amanda Maxwell
9. Accelerating Access to in vitro Diagnostics: Urgent

Need for Increasing the Speed and Efficiency of
Regulatory Review and Policy Development for in vitro
Diagnostics for Antimicrobial Resistance and Epidemic
Preparedness and Response 73
Rosanna W. Peeling, David Heymann, Noah Fongwen,
Oliver Williams, Joanna Wiecek, Phil Packer, and
Gabriela Juarez-Martinez
9.1 Background 73
9.2 The Need for Regulatory Harmonization,
Convergence and Reliance for in vitro
Diagnostics 76
9.3 Need for a New Paradigm for Risk-Benefit
Assessment for Diagnostics 77
9.4 Next Steps 82
Contents ix
10. Regulatory Specialists in Medical Devices in Europe:

Meeting the Challenge of Keeping Current in a
Changing Environment—How TOPRA Supports
Professionals in a Dynamic Industry 85
Lynda J. Wight
10.1 The European MedTech Environment 85

10.2 What Is TOPRA? 87
10.3 Why Be a TOPRA Member? 87
10.4 What Support Is Offered? 88
10.4.1 Competency Frameworks 88
10.4.2 Training and Development 89
10.4.3 Education 90
10.4.4 Networks and Collaborations 91
10.4.5 Information 91
10.5 Looking to the Future 91
Part 2: Medical Device Safety and Related ISO Standards
11. Biomedical Devices: Overview 95

Piu Wong
11.1 Historic Aspect of Medical Devices 95

11.2 Biomedical Market Environment 97
11.3 Orthopedics 98
11.3.1 Market 98
11.3.2 Materials 99
11.3.3 Biocompatibility 99
11.3.4 Fabrication 100
11.3.5 Polyethylene Fabrication 100
11.4 Vision Care 102
11.4.1 Market 102
11.4.2 Diagnostic Devices 102
11.4.3 Treatment 103
11.5 Diabetics 104
11.6 Obesity 104
x Contents
11.7 Vascular Disease 104

11.8 Concluding Remarks 105
12. Labeling, Label, and Language: A Truly Global Matter 109

Evangeline D. Loh and Jaap L. Laufer
12.1 Introduction 109

12.2 Definition of Labeling 111
12.3 Elements of Labeling 113
12.4 Risk Management, Clinical Evaluation and
Labeling: The Core Triangle for Safe and
Effective Use of the Device 115
12.5 Labeling and Promotion 117
12.6 e-Labeling, Web Sites, Internet, and Social
Media: A Brave New World for Labeling 117
12.7 Language, Language Level, and Intended User 119
12.8 Conclusion 121
13. Regulatory Affairs for Medical Device Clinical Trials

in Asia Pacific 123
Seow Li-Ping Geraldine

13.2 Medical Device Clinical Trials versus
Pharmaceutical Clinical Trials 124
13.3 Regulation of Clinical Trials 127
13.4 Country Regulations 133
13.4.1 Australia 133
13.4.2 China 135
13.4.3 Hong Kong 136
13.4.4 India 136
13.4.5 Malaysia 137
13.4.6 New Zealand 137
13.4.7 Singapore 138
13.4.8 South Korea 139
13.4.9 Taiwan 140
13.4.10 Thailand 141
13.5 Moving Ahead as Regulatory Affairs Professionals 141
Contents xi
14. Medical Device Classification Guide 145

Patricia Teysseyre
14.1 How to Carry Out Medical Device Classification 145

14.1.1 Scope 145
14.1.2 Definitions 146
14.2 Main Classifications 147
14.2.1 Medical Devices 147
14.2.2 Active Devices 147
14.2.3 IVD Devices 148
14.2.4 IVD Case Study 150
14.2.4.1 US FDA 151
14.2.4.2 Canada 151
14.2.4.3 EU 152
14.2.4.4 Singapore 153
14.3 Medical Device Classification: Practical
Examples 153
15. ISO 13485:2016: Medical Devices—Quality

Management Systems—Requirements for
Regulatory Purposes 169
Gert Bos

15.2 Background and Origins of ISO 13485:2016 170
15.3 Quality Management Systems 172
15.4 ISO 9000 and ISO 13485 Quality Management
System Family of Standards 173
15.5 Global Regulatory Footprint of ISO 13485:2016 174
15.6 Implementing an ISO 13485:2016 Quality
Management System 175
15.7 Process Approach 175
15.8 Planning the Implementation 176
15.9 Scope, Exclusions and Non-Applicability 178
15.10 Document Control 178
15.11 Record Completion and Control 178
15.12 Management Responsibility 179
xii Contents
15.13 Resource Management 180

15.14 Product Realization 180
15.15 Risk Management 181
15.16 Design and Development 182
15.17 Purchasing and Supplier Control 183
15.18 Production and Service Provision 184
15.19 Monitoring and Measuring, Including Internal
Audits and Management Review 184
15.20 Control of Non-Conforming Product 185
15.21 Analysis of Data 185
15.22 Improvement: Corrective Action and
Preventive Action 186
15.23 Purpose and Goal of ISO 13485:2016
Certification 187
15.24 Achieving Certification and Continuing to
Maintain Certification 187
16. ISO 14971: Application of Risk Management to

Medical Devices 191
Tony Chan and Raymond K. Y. Tong

16.2 The Foundation of a Risk Management
Framework: Policy, Plan, Team, Process, and
Documentation 194
16.2.1 Policy 195
16.2.2 Plan 195
16.2.3 Team 195
16.2.4 Process 195
16.2.5 Documentation 196
16.3 The RM Process 196
16.3.1 Analyze Risk 196
16.3.2 Evaluate Risk 197
16.3.3 Control Risk 197
16.3.4 Feedback from Production and
Post-Production Information 199
Contents xiii
16.4 Conclusion 200

16.5 Case Study—An Example to Illustrate Risk
Management on a Medical Device: Functional
Electrical Stimulation System for Walking 200
16.5.1 Risk Management Process 202
17. Medical Devices—IEC International Standards and

Conformity Assessment Services in Support of
Medical Regulation and Governance 209
Gabriela Ehrlich

17.2 What Is an IEC International Standard? 211
17.3 How Are IEC International Standards
Developed? 211
17.4 IEC International Standards for Medical
Devices 212
17.5 Conformity Assessment for Medical Devices 214
17.6 Conclusion 216
18. Good Submission Practice 217

Shinji Hatakeyama and Isao Sasaki
18.1 Preamble 217

18.2.1 Objective and Scope 218
18.2.2 Background 219
18.2.3 Definition 220
18.3 Principles of Good Submission 220
18.4 Management of Submission 222
18.4.1 Planning for Submission 222
18.4.2 Preparation and Submission of
Application Dossier 224
18.4.3 Quality Check 227
18.5 Communications 228
18.5.1 Communications with the Review
Authorities 228
xiv Contents
18.5.2Communication within Applicants’

Organization 231
18.6 Competencies and Training 231
18.6.1 Core Competency of Applicants 232
18.6.2 Training and Capacity Building 233
18.7 Conclusion 233
Part 3: Medical Device Regulatory System in the United States,

European Union, Saudi Arabia, and Latin America
19. United States Medical Device Regulatory Framework 237

Joshua Silverstein

19.2 FDA’s Center for Devices and Radiological
Health 238
19.3 Legislation and Device Law 239
19.3.1 FDA Law vs. FDA Regulations vs. FDA
Guidance 240
19.4 The Regulatory Environment for Bringing a
Medical Device to Market 241
19.5 Regulatory Considerations for Medical Devices 241
19.5.1 Definition of Medical Devices 241
19.5.2 Classification of Medical Devices 242
19.5.2.1 General controls 246
19.5.2.2 Special controls 246
19.5.2.3 Premarket approval 247
19.5.3 Convenience Kits 247
19.5.4 Labeling 248
19.5.5 Adulteration and Misbranding 248
19.5.6 Establishment Registration and
Medical Device Listing 249
19.5.7 Quality System Regulation/Good
Manufacturing Practices 249
19.5.8 Medical Device Reporting 250
19.5.9 Unique Device Identification 251
Contents xv
19.5.10 User Fees 252

19.6 Premarket Submissions for Medical Devices 252
19.6.1 eCopy Program for Medical Device
Submissions 253
19.6.2 Premarket Notification (510(k)) 253
19.6.2.1 Predicate device and
substantial equivalence 253
19.6.3 De novo Classification Request 255
19.6.4 Premarket Approval Application 256
19.6.5 Accessory Requests 257
19.6.6 Investigational Device Exemption 258
19.6.7 Q-Submissions: Requesting Feedback
and Meeting with FDA 258
19.6.8 Promoting Innovation: Breakthrough
Devices 259
19.7 Summary 260
20. Regulation of Combination Products in the United

States 263
John Barlow Weiner and Thinh X. Nguyen
20.1 What Products Are Considered Combination

Products 264
20.2 The Standards for Determining If a Product Is a
Combination Product 264
20.3 The Standards for Determining Which FDA
Component Has Primary Responsibility for
Regulating a Combination Product 266
20.4 Requests for Designation 267
20.5 Premarket Review Considerations 268
20.6 Post-Market Regulatory Considerations 269
20.7 Role of Office of Combination Products 270
20.8 International Harmonization and Coordination
Activities with Foreign Counterparts 270
20.9 FDA Resources for Obtaining Additional
Information 271
xvi Contents
21. European Union Medical Device Regulatory System 273

Arkan Zwick and Gert Bos
21.1 Glossary of Terms 273

21.2 European Union: Medical Device Market and
Structure 275
21.3 EU Regulations on Medical Devices 278
21.4 Harmonized Standards, Presumption of
Conformity and State of the Art 278
21.5 European Associations 281
21.6 Overview of New Medical Devices Regulations 285
21.7 Guidelines MEDDEV/NB-MED 286
21.8 Guidelines MDCG and Common Specifications 287
21.9 Definitions 289
21.9.1 Medical Device 289
21.9.2 Devices without Medical Purpose 290
21.9.3 CE Mark 290
21.9.4 European Commission and MDCG 292
21.9.5 Competent Authority
21.9.6 Notified Body—Conformity
Assessment Body 293
21.9.7 The Manufacturer 295
21.9.8 Authorized Representative 296
21.10 Classification 297
21.10.1 Medical Devices 297
21.10.2 Active Implantable Medical Devices 298
21.10.3 In Vitro and Diagnostics Medical
Devices 299
21.11 Conformity Assessment Procedures 300
21.12 General Safety and Performance Requirements 304
21.13 Labeling 305
21.14 Technical Documentation 305
21.15 Quality Management System 307
21.16 Risk Management 308
21.17 Clinical Evaluation 309
Contents xvii
21.18 CE Mark Certificate and Declaration of

Conformity 311
21.19 Post-Market Surveillance 312
21.20 From MDD to MDR 313
21.21 Transition and MDR Impact 314
21.22 General Safety and Performance Requirements 314
21.23 Stronger Notified Body Oversight 315
21.24 Economic Operators 315
21.25 Clinical Evidence, Postmarked Follow-Up and
Risk Reviews 316
21.26 PSUR/PMCF Reports 316
21.27 UK Leaving the EU—BREXIT 317
22. Regulation of Combination Products in the European

Union 321
Gert Bos
22.1 Introduction: Legal Basis 321

22.1.1 Definitions 323
22.1.1.1 Medical device 323
22.1.1.2 Medicinal product 323
22.1.1.3 Combination products:
Principal mode of action 324
22.1.1.4 Borderline products:
MEDDEV 2.1/3 325
22.1.1.5 Borderline products:
Manual of decisions 326
22.2 Combination Products Regulated as Medicinal
Products 326
22.2.1 Examples of Combination Products
Regulated as Medicinal Products 326
22.3 Combination Products Regulated as Medical
Devices 327
22.3.1 Examples of Combination Products
Regulated as Drug-Delivery Devices 327
22.4 Combination Products Regulated as Devices
Incorporating, as an Integral Part, an Ancillary
Medicinal Substance 327
xviii Contents
22.4.1 Examples of Devices Incorporating an

Ancillary Medicinal Substance 328
22.4.2 Examples of Drug Substances
Incorporated into Devices 328
22.4.3 Assessment of the Medicinal Substance
Aspects of a Device Incorporating an
Ancillary Medicinal Substance 329
22.5 The Consultation Process 330
22.6 Information to Be Provided on the Ancillary
22.6.1 General 330
22.6.1 Quality 330
22.6.2 Safety and Usefulness 331
22.6.3 Guidance 331
22.7 Combination Products Regulated as Drugs
Incorporating, as an Integral Part, an Ancillary
22.8 Other Combination Products 332
23. Medical Device Regulatory Affairs in Latin America 335

Carolina Cera and Gladys Servia

23.2 Latin America Market Analysis 336
23.2.1 Medical Device Market in Latin America 336
23.2.2 Trade Blocs 337
23.3 Overview of Medical Device Regulation in
Latin America 338
23.3.1 Evolution of the Medical Device
Regulation in Latin America 338
23.3.2 Regulatory Environment in Latin
America 339
23.3.2.1 Finding local registration
holder 339
23.3.2.2 Harmonization of medical
device 340
23.3.2.3 Challenges in the region 341
Contents xix
23.4 Argentina and Brazil Medical Device System 342

23.4.1 Definition of Medical Device 343
23.4.3 Argentina Medical Device System 343
23.4.3.1 Regulatory authority and
medical device regulation 343
23.4.3.2 Registration process of
medical devices 344
23.4.3.3 Documents and labeling
requirements 344
23.4.3.4 Official registration fee 345
23.4.3.5 Timeline 346
23.4.3.6 Regulatory action for
changes and device
modifications 346
23.4.3.7 Post-market surveillance 346
23.4.4 Brazil Medical Device System 347
23.4.4.1 Registration process of
medical devices in Brazil 347
requirements 349
23.4.4.4 Timeline 350
changes and device
modification 351
23.5 Colombia Medical Device System 352
23.5.1 Regulatory Authority and Medical
Device Regulation 352
23.5.4 Registration of Medical Devices 354
23.5.4.1 Regulatory process 354
23.5.4.2 Documents required 354
xx Contents
23.5.4.4 Timeline 356

23.5.4.5 Regulatory action for changes
and device modifications 356
23.6 Mexico Medical Device System 357
23.6.1 Regulatory Authority and Medical
Device Regulation 357
23.6.4 Registration of Medical Devices 359
23.6.4.1 Registration process 359
requirements 359
23.6.4.4 Timeline 361
changes and device
modifications 361
23.6.5 Post-Market Surveillance 361
24. Saudi Arabia: Medical Device Regulation System 363

Ali Aldalaan

24.2 Legislative Responsibilities 364
24.3 Executive Responsibilities 364
24.4 Surveillance Responsibilities 365
24.5 Regulation Overview 366
24.6 Registration Requirements 367
24.7 Information to Be Provided to the SFDA 367
24.8 Medical Device Marketing Authorization 369
24.9 Medical Device Listing 370
24.10 Registration Fees 370
24.10.1 Medical Device Marketing
Authorization 370
24.10.2 Medical Device Authorized
Representative License 371
Contents xxi
24.10.3 Medical Device Establishment

Licensing 371
24.11 General Information and Documentary
Evidence Need to Be Provided to the SFDA 371
24.12 Labeling Requirement for Medical Device 372
24.13 Clinical Investigation 374
24.14 Post-Market Surveillance Requirement 376
24.14.1 General 376
24.14.2 Proactive Surveillance and Risk
Assessment Activities 377
24.14.3 Reactive Surveillance/Vigilance
Activities 378
24.14.3.1 Medical devices’ management
for incidents and adverse
events 379
24.14.3.2 Medical device field safety
corrective actions 380
24.14.4 Confidentiality of Information 380
Part 4: Medical Device Regulatory System in

Asia-Pacific Region
25. Australian Medical Device Regulations: An Overview 387

Petahn McKenna
25.1 Medical Device Market in Australia 387

25.2 Medical Device Regulations 388
25.2.1 Overview 388
25.2.2 Regulating Authority 389
25.2.3 Legislation and Guidance 389
25.3 Definition of Medical Device 389
25.4 Classification of Medical Devices 390
25.4.1 Classification of IVD Medical Devices 391
25.5 Inclusion of Medical Devices on the ARTG 392
25.5.1 Process for Supplying a Medical Device
in Australia 392
xxii Contents
25.5.2 Process for Including Class 1 IVD

Medical Devices in the ARTG 395
25.5.3 Process for Including IVD Medical
Devices in the ARTG 396
25.6 Same Kind of Medical Device 398
25.7 Unique Product Identifier 398
25.8 In vitro Diagnostic UPIs 399
25.9 Renewal 400
25.10 Documentation Requirements 400
25.10.1 Conformity Assessment Applications 400
25.11 Application Audits 401
25.12 Access to Unapproved Medical Devices 402
26. China: Medical Device Regulatory System 403

Jack Wong

26.2 Market Overview 404
26.3 Overview of Regulatory Environment and
What Laws/Regulations Govern the Medical
Devices 404
26.3.1 Guidance 406
26.3.2 Standards 406
26.4 Regulatory Body 407
26.5 Regulatory Overview 408
26.5.3 Filing Process for Class I Medical
Device 410
26.5.4 Registration Process for Class II or III
Medical Device 411
26.5.4.1 Medical device registration
certificate 411
26.5.4.2 Documents needed for
registration application 414
Contents xxiii
26.5.4.3 Product technical

requirements and
registration testing 415
26.5.4.4 Biocompatibility evaluation 415
26.5.4.5 Clinical evaluation and
clinical trials 416
26.5.4.6 Enforcing GMPs 423
26.5.4.7 Timeframes 424
26.5.4.8 Registration alteration 424
26.5.4.9 Registration renewal 426
26.5.4.10 The registration fee 426
26.5.4.11 Innovative medical devices 427
26.5.4.12 Drug/device combination
products 427
26.6 Monitoring Adverse Events 428
26.6.1 AE Reporting 428
26.6.2 Periodic Risk Assessment Report 429
26.7 Managing Recalls 429
27. Hong Kong: Medical Device Regulatory System 433

Jack Wong and Linda Chan

27.1.1 Market Environment 433
27.1.2 Overview of Regulatory Environment
and What Laws/Regulations Govern
Medical Devices 434
27.1.3 Regulatory Body 435
27.2.1 The Definition of Medical Device 436
27.2.3 The Role of Distributors or Local
Subsidiaries 438
27.2.4 Product Registration or Conformity
Assessment Route and Time Required 439
xxiv Contents
27.2.4.1 Suggested registration

routes/steps 440
27.2.4.2 Technical material
requirement 441
27.2.4.3 The labeling requirement of
medical device 441
27.2.4.4 Post-marketing surveillance
requirement 442
27.2.4.5 Manufacturing-related
regulation 442
27.2.4.6 Clinical trial related
regulation 442
27.2.4.7 Is there a procedure for
mutual recognition of foreign
marketing approval or
international standards? 443
27.3 Commercial Aspects 443
27.4 Upcoming Events 443
28. India: Medical Device Regulatory System 445

Kulwant S. Saini

28.1.1 Market Environment 445
and What Laws/Regulations Govern
Medical Devices 446
28.1.3 Functions Undertaken by DCGI and
Central Government 450
28.1.3.1 Statutory functions 450
28.1.3.2 Other functions 450
28.1.4 Functions Undertaken by the FDA and
State Governments 451
28.1.4.1 Statutory functions 451
28.1.5 Guidance Documents 452
28.1.6 Indian Pharmacopoeial Commission 453
28.1.7 Detail of Key Regulator(s) 453
Contents xxv

28.2.3 Role of Distributors or Local
Subsidiaries 457
28.2.4 Product Registration or Conformity
Assessment Route and Time Required 458
28.2.5 Quality System Regulation 460
28.2.6 Product Registration and Quality System
Regulation for Combined Device–Drug
Product 460
28.2.7 Registration Fee 461
28.2.8 Technical Material Requirement 462
28.2.9 The Labelling Requirement of Medical
Device 462
28.2.10 Post-Marketing Surveillance
Requirement 463
28.2.11 Manufacturing-Related Regulation 463
28.2.12 Clinical Trial-Related Regulation 464
28.2.13 Is There a Procedure for Mutual
Recognition of Foreign Marketing
Approval or International Standards? 465
28.3.1 Any Price Control of Medical Device 465
28.3.2 Are Parallel Imports Allowed? 466
28.3.3 Any Advertisement Regulation of
Medical Device? 466
28.4 Upcoming Regulation Changes 466
28.5 Related Agencies/Departments and Ministries 468
29. Indonesia: Medical Device Regulatory System 469

Mita Rosalina

29.2 Regulating Authority 471
xxvi Contents
29.4 Classification of Medical Devices 472

29.5 Registration of Medical Devices 473
29.5.1 Process 473
29.5.2 Documents Required 474
29.5.3 Official Registration Fee 474
29.5.4 Time Line 474
29.5.5 Validity of Product License 475
29.5.6 Indonesian Labeling Requirement 475
29.5.7 Regulatory Action for Changes and
Device Modifications 475
29.6 Post-Market Surveillance System 476
30. Japan: Medical Device Regulatory System 491

Atsushi Tamura and Keizo Matsukawa

30.2 Regulatory Agency in Japan 492
30.2.1 Ministry of Health Labour and
Welfare/MHLW 492
30.2.2 Pharmaceuticals and Medical Devices
Agency 492
30.2.3 PMDA Medical Device Unit 495
30.2.4 Shared Responsibility of MHLW and
PMDA on Medical Device Regulation 495
30.3 Legislation of Medical Devices 497
30.3.2 Type of Product’s Registration 500
30.3.2.1 Notification of marketing 500
30.3.2.2 Certification 500
30.3.2.3 Approval 501
30.3.3 Marketing Licenses 502
30.3.4 Marketing Authorization Holder 503
30.3.5 Accreditation of Manufacturing
Businesses/Accreditation of Foreign
Manufactures of Medical Devices 504
30.3.6 Registered Certification Bodies 505
Contents xxvii

30.4.1 QMS Ordinance 507
30.4.1.1 QMS conformity as an
essential requirement 508
30.4.2 QMS Organizational Structure and
Personnel Requirements 509
30.4.3 QMS Inspections 510
30.5 Post Market Safety Management 510
30.5.1 GVP Ordinance 511
30.5.2 Requirements for MAH 513
30.5.3 Collection, Analysis and Reporting of
Post-marketing Safety Information 513
30.5.3.1 Obligations of MAH 513
30.5.4 Recall 515
30.5.4.1 Obligations of healthcare
professional 516
30.5.5 PMDA’s Obligations during Post-Market
Phase 516
30.5.5.1 Various approaches 517
30.5.5.2 Information services 517
30.6 New Regulatory Challenge 518
30.6.1 SAKIGAKE Designation System 519
30.6.2 Conditional Early Approval System 522
30.6.3 Introduction of Approval System
Based on the Characteristics of
Medical Devices 522
30.6.3.1 Early realization of change
plan 525
30.6.3.2 Improvement design within
approval for timely evaluation
and notice 525
30.6.4 Electronic Labelling/Instructions for Use 525
30.6.5 PMDA-ATC Medical Device Seminar 526
30.6.6 Guidance for the Evaluation of Emerging
Technology Medical Devices 527
xxviii Contents
30.6.6.1 PMDA Science Board 527

30.6.6.2 Publication of the guidance
for the evaluation of
next-generation medical
devices 527
30.6.7 Traceability 530
30.6.8 Information Services 530
30.6.9 Harmonization by Doing 532
31. Korea: Medical Device Regulatory System 535

Young Kim, Soo Kyeong Shin, and Jamie Noh
31.1 General Market Overview 535

31.1.1 Key Healthcare Market Indicators
of Korea 535
31.1.2 Medical Device Market 538
31.1.3 Import 540
31.1.4 Domestic Production 544
31.1.5 Export 551
31.2 Regulatory Approvals 551
31.2.1 Responsible Authorities 551
31.2.2 Qualifications for Medical Device
Business 553
31.2.2.1 Medical device business
license 553
31.2.2.2 Certification to medical
device quality system
management 554
31.2.2.3 Medical device product
approval or certification or
notification 554
31.2.3 Strategic Plan and Useful Tips for
Efficient Registration 561
31.2.3.1 Face-to-face meeting with
reviewer 561
31.2.3.2 Respond to reviewer’s
questions with respect 562
Contents xxix
31.2.3.3 Retain experienced regulatory

affairs professionals 562
31.3 Reimbursement 563
31.3.1 Overview of Reimbursement Scheme 563
31.3.2 Medical Supplies 565
31.3.2.1 Submission 565
31.3.2.2 Pricing options 566
31.3.2.3 Timeframes 567
31.3.2.4 Stakeholders 568
31.3.3 Health Technology Assessment 570
32. Overview of Medical Device Regulation in Malaysia 573

Ir. Sasikala Devi Thangavelu
32.1 Medical Device Industry in Malaysia 573

32.2 Medical Device Regulatory Program 574
32.3 Introduction to Medical Device Act 2012 575
32.3 Establishment license 577
32.4 Medical Device Registration 580
32.4.1 Classification and Grouping for the
Purpose of Medical Device Registration 581
32.4.2 Conformity Assessment 584
32.4.6 Conformity Assessment through
Verification Route 585
32.5 Combinational Medical Devices 587
32.5.1 Definition of Combination Product 587
32.5.2 Registration Process of Combination
Product 588
32.5.3 Drug-Medical Device Combination
Product Registration Process 590
32.5.4 Medical Device-Drug Combination
Product Registration Process 590
32.5.5 Changes/Variation to Particulars of a
Registered Drug-Medical Device
xxx Contents
32.5.6 Changes/Variation to Particulars of a

Registered Medical Device-Drug
32.7 Medical Device Labelling 591
32.7.1 General Contents of Labelling 593
32.7.2 Additional Information for in vitro
Diagnostic Medical Devices 593
32.8 Medical Device Order 2016 594
32.9 Post-Market Surveillance and Vigilance 595
32.9.1 Distribution Records 595
32.9.2 Records of Complaint Handling 595
32.9.3 Mandatory Problem Reporting 595
32.9.4 Field Corrective Preventive Action 596
32.9.5 Recall 596
32.9.6 Voluntary Recall 596
32.9.7 Mandatory Recall 597
32.10 Regulatory Action for Changes and Device
Modifications 597
32.10.1 Change Notification for Registered
Medical Device 597
32.10.2 Refurbishment of Medical Device 598
32.11 Regulatory Control on Usage, Operation, and
Maintenance of Medical Devices 599
33. The Philippine Medical Device Regulatory System 601

Rhoel Laderas
33.1 The Medical Device Market Profile 601

33.2 Introduction to the Philippines Regulatory
System 602
33.2 The Medical Device Regulatory System 603
33.2.1 The Licensing of Medical Device
Establishment 603
32.2.2 The Authorizations for Medical Device
Products 607
Contents xxxi
34. Singapore Medical Device Regulation 619

May Ng, Ray Soh, Trish, Beatrice, Bing Kang, Yiyu, Xinyu,
Ivy Lim, and Tiffany Hu

34.2 Classification of Medical Device 621
34.3 Singapore Medical Device Notification,
Registration and Other Authorisations 623
34.3.1 Steps to Access MEDICS 623
34.3.2 Establishment or Dealer Licenses 624
34.3.3 Class A Notification 626
34.3.4 Class B, C and D Pre-Market Product
registration 626
34.3.5 Special Authorisation Routes in
Singapore 633
34.4 Post-Market Surveillance 637
34.4.1 Adverse Event 637
34.4.2 Field Safety Corrective Action 638
34.5 Medical Device Advertisement 639
34.6 Clinical Trial in Singapore 640
34.7 Price Control on Medical Device 641
35. Taiwan: Medical Device Regulatory System

Introduction 643
Pei-Weng Tu

35.1.1 Overview of Structure and Funding of
Local Healthcare System 643
and Laws/Regulations Governing
Medical Devices 645
35.1.3 Detail of Key Regulator(s) 646
35.2.2 Classification of Medical Device 648
xxxii Contents
35.2.3 Role of Distributors or Local Subsidiaries 648

35.2.4 Product Registration, Technical
Material Requirement, and Time
Required 649
35.3 Quality System Regulation 650
35.4 Combined Device–Drug Product 650
35.5 Registration Fee 650
35.6 Labeling Requirements of Medical Devices 650
35.7 Post-Marketing Surveillance Requirement 650
35.8 Manufacturing-Related Regulation 651
35.9 Clinical Trial–Related Regulation 651
35.10 International Cooperation 651
35.11.1 Price Control of Medical Device 653
35.11.2 Parallel Imports 653
35.11.3 Advertisement Regulation of Medical
Devices 653
35.12 Upcoming Events 653
36. Thailand: Medical Device Control and Regulation 655

Kanokorn Pulsiri, Sirinmas Katchamart, Sansanee Pinthong,
and Korrapat Trisansri

36.2 Medical Device Regulations 656
36.4 Medical Device Classification 658
36.5 Pre-Marketing Control 659
36.5.1 Documents Required for Medical
Device Registration 659
36.5.1.1 Licensed medical device and
notified medical device 659
36.5.1.2 Listing 661
36.5.2 Labeling 662
36.5.3 Advertising 663
36.6 Post-Market Controls 663
Contents xxxiii
37. Vietnam 667

Nguyen Minh Tuan
37.1 Market Environment 667
37.2 Roadmap for the Implementation of the Decree
on Medical Device Management 668
37.3 License Fees 671
37.4 Labelling According to New Rules 671
37.5 Technical Requirements for Raw Materials 672
37.6 Domestic Production 672
37.7 Clinical Trial Evaluation 672
Part 5: Hot Topics

38. A Strong Regulatory Strategy Is a Competitive
Advantage to a Medical Device Company 677
Jacky Devergne
38.1 Competitive Advantage 678

38.1.1 Time to Market 678
38.1.2 Barriers of Entry 679
38.1.3 Continuity of Business 679
38.1.4 Best Use of Resources 680
38.2 The Right Organization 681
38.2.1 Investing in an Effective RA
Organization 681
38.2.2 Integrating RA in Business Planning 681
38.3 Conclusion 682
39. Regulatory Strategy: An Overview 683

Pakhi Rusia

39.2 The Significance of Regulatory Strategy 685
39.3 Key Steps to Develop Regulatory Strategy 686
39.3.1 Defining Project Scope 686
39.3.2 Defining Timelines and Milestones 687
39.3.3 Stakeholder Alignment 687
xxxiv Contents
39.4 Key Factors to Be Considered for Developing

Regulatory Strategy 687
39.4.1 Identification of Project Attributes 688
39.4.2 Geography and Regulatory Landscape 689
39.5 Implementing the Regulatory Strategy 690
39.6 Conclusion 691
40. Leading the New Normal by Accelerating Digital

Transformation 693
Virginia Chan
40.1 China Medical Technology Market in 2025 693

40.2 Patient-Centric Digital Healthcare Model 694
40.3 Accelerate Digital Transformation for Agility,
Flexibility, Efficiency, Reimagine the New
Business Model 695
40.4 Digital Health Regulation: Focus on Quality
Across the Product Life Cycle 695
40.5 Connected Care 696
40.6 Intelligent Design Control to Shorten
Time-to-Market with Compliance 697
40.7 Digital Innovation for Design Excellence:
Augment Virtual Evidence to Reduce Design
Time and Cost with in silico Clinical Trials 697
40.8 Turning Complexity to Your Competitive
Advantage: Gain Digital Dividend with
Vision 2025 699
41. An Overview of the Herbal Product Regulatory

Classification in Asia and General Guidelines for
Health Product Development 701
Jacob Cheong
42. Overview of Health Supplements: Singapore 707

Srilatha Sreepathy, Geeta Pradeep, and A. V. Rukmini

42.2 What Are Health Supplements? 708
Contents xxxv
42.3 What Are Not Health Supplements? 709

42.4 How Are Health Supplements Regulated in
Singapore? 709
42.5 Safety and Quality Standards 709
42.6 Quality Standards 710
42.7 Stability Study and Shelf-Life of Health
Supplements 712
42.8 Storage Condition 712
42.9 Product Labelling Requirement 713
42.10 Health Supplement Claims 714
42.11 Advertisements and Promotions 715
42.12 Other Important Aspects 715
43. International Medical Device School Experience 719

Encey Yao
44. Medtech Start-Up: Journey to First Product Approval 723

Sing Wee, Joel Tan, and Trish, May Ng

44.2 Intended Use 724
44.3 Technical Documentation 725
44.5 Clinical Evaluation 727
44.6 Conclusion 728
45. Digital Transformation of Healthcare and Venture

Capital’s Role in It 729
Mark Wang
46. A Regulatory Career in Asia 737

Ambrose Chan
46.1 Hiring Landscape in Asia 737

46.2 Opportunities across Markets 738
46.3 Getting Ahead in your Search 740
xxxvi Contents
47. A Former FDA Investigator’s Views on Compliance

with the Medical Device Regulations 743
Ken Miles
Index 751
Preface
Medical device regulation in Asian markets has become

important. Governments and regulatory bodies of countries
across the region have placed new regulatory systems or refined
the existing ones. Regulatory affairs (RA) is a science of how
to get a medical product registered with different countries’
health authorities. A registered product would demand a lot of
technical documentation to prove its efficacy, safety, and quality.
To successfully and smoothly register a product, many soft
skills are required for dealing with various key stakeholders in
governments, testing centers, hospitals, and medical doctors.
The handbook is the first to cover medical device regulatory
affairs in Asia. It is enriched by contributions by authors working
with several regulatory bodies, including the US Food and Drug
Administration (FDA), UK Medicines and Healthcare Products
Regulatory Agency (MHRA), Japan Pharmaceuticals and Medical
Devices Agency (PMDA), Saudi Food and Drug Authority (SFDA),
Taiwan FDA). Each chapter provides substantial background
materials relevant to a particular area to provide the reader a
better understanding of regulatory affairs. The text also presents
in-depth discussion on requirements for medical device registration
in China and India.
Government bodies will find this book useful to understand
the global regulatory environment to help enhance their regulatory
systems. The medical device industry can use it to better understand
and access the Asian market. Academics and students will find
this book very important for their careers in biomedical
engineering and medical device–related fields. In research and
development, with the help of this book, companies can plan
their projects and ensure that the developed medical devices
adhere to the global regulatory environment.
xxxviii Preface
The chapters have been grouped into four main parts as

follows:
• Part 1 explains what RA is, how to be a good RA professional,
how a RA professional works with other team members,
and some associated soft skills.
• Part 2 focuses on medical device fundamentals, such as
history, labeling requirement, clinical trial requirement,
how to do classification, and two important standards for
medical device regulatory (ISO 13485 and ISO 14971), IEC
standard and Good Submission Practice.
• Part 3 discusses in detail the regulatory systems in the
United States, the European Union, Saudi Arabia, and Latin
America. These are important markets outside Asia. Their
experience will be very helpful for Asia.
• Part 4 is the core of this book. It describes the regulatory
system in the Asian market, with contributions from regulatory
authorities, testing laboratories, and industries.
• Part 5 shares the hot topics in the regulatory field, including
regulatory strategy, digital transformation, herbal regulatory
system, health supplements, International Medical Device
School, medtech start-up journey, regulatory career in Asia,
and a former FDA investigator’s perspective.
This book would not have been possible without contributions
from outstanding experts in various topics discussed in it. We wish
to express our gratitude to all of them for their precious efforts and
strong support.
Fifty percent of the revenue from this book will be donated to
the Asia Regulatory Professionals Association and the remaining
50% to the Department of Biomedical Engineering, the Chinese
University of Hong Kong—both are for the development of medical
device regulatory affairs in Asia.
Finally, many thanks to our families (Jack Wong’s mother,
Cheung Shim Kuen, wife, Sherry Kwan, and son, Jay Wong; Raymond
Tong’s parents, Wai-chuen Tong and Lai-lin Tsui, wife, Wai-nga Lam,
Preface xxxix
and daughter and sons, Lok-ching, Lok-tin, and Lok-ting), for their
support, encouragement, and patience. They have been our driving
forces.
Jack Wong
Asia Regulatory Professional Association
Raymond Kai-yu Tong

Professor, Department of Biomedical Engineering (BME),
The Chinese University of Hong Kong (CUHK)
Hong Kong Academy Chair, Asia Regulatory Professionals Association
Chapter 1
How to Train University Students in

Regulatory Affairs to Face the Medical
Devices Market Growth after the
COVID-19 Impact
Raymond K. Y. Tong
Department of Biomedical Engineering,
The Chinese University of Hong Kong, Shatin, Hong Kong
Asia Regulatory Professional Association (ARPA)
kytong@cuhk.edu.hk
This chapter focuses on how to design a regulatory course to train

university students in regulatory affairs.
1.1 Introduction
Medical device regulation comes with new framework, new
principal and supportive responsibilities in Asian and European
countries. The COVID-19 pandemic has created the largest
disruption of healthcare and education systems in history. The
demand of medical devices for vaccination, diagnosis, treatment
and telehealth purposes has surged. The Medical Devices Market
Size was valued at US$ 483,285.8 million in 2019 and is projected
to reach US$ 767,684.9 million by 2027 [1]. The compound
Medical Regulatory Affairs: An International Handbook for Medical Devices

and Healthcare Products (Third Edition)
Edited by Jack Wong and Raymond K. Y. Tong
Copyright © 2022 Jenny Stanford Publishing Pte. Ltd.
ISBN 978-981-4877-86-2 (Hardcover), 978-1-003-20769-6 (eBook)
www.jennystanford.com
2 The Medical Devices Market Growth after the COVID-19 Impact
annual growth rate (CAGR) is estimated to be 6.1% from 2020 to

2027. Asian markets have significant growth. The market in China
reached US$ 78.81 billion in 2018, at a rate of 22% from 2017.
The Indian medical device market reached US$ 6 billion in 2017
and is projected to reach US$ 50 billion by 2025 [1]. The Medical
Device Regulation (MDR), which was adopted in April 2017,
changes the European legal framework for medical devices and
introduces new principal and supportive responsibilities for
European Medicines Agency and for national competent authorities
in the assessment of certain categories of products. The course
should be suitable for students who are studying biomedical
engineering, biomedical science, healthcare, or medical device
engineering. These students should have some experience in
a health- or engineering-related field and should wish to start
working in the growing field of regulatory affairs. The course in
regulatory affairs aims to give both factual and practical knowledge
of what is regulatory requirement and how to handle future
regulatory tasks. On completion of the course, students will be
able to demonstrate their understanding of how to meet the
standards and regulatory requirements, and they will be able to
handle regulatory tasks, including classification, risk management,
ISO standard, product registration, and commercial materials
review.
Students will be trained to understand the global, regional, and
local medical device regulatory requirements and trends. Besides
conducting lectures, students will be arranged into a small group to
work on a medical device and practice preparing a medical device
registration submission to a competent authority. The competent
authority is a body that has authority to act on behalf of the
government to ensure that the requirements of the medical device
directives are transposed into the national law and are applied.
Guest lecturers with regulatory experience and network will be
invited to share their experience. Students who finish the course
will be eligible for attending related medical device regulatory
examination conducted by external bodies, such as notified
bodies and the Asia Regulatory Professional Association.
A Sample of Regulatory Affairs Exercises for Students 3
1.2 A Sample of Regulatory Affairs Exercises

for Students
1.2.1 Background
Consider this case. You have just been recruited by a manufacturing
company, Poly Technologies Corporation (PTC), as project
manager under its newly found business section for medical and
healthcare products. The company has little, if any, experience
in designing and manufacturing medical devices. Your primary
duty is to provide internal consultancy to the top management
of the company on new business development analysis and
management of medical device design and manufacturing projects.
Last month your company’s top management signed a business
agreement to collaborate with an overseas client, which is a
global distributor of medical products. Under this collaboration
agreement, your client and PTC will co-develop a series of medical
devices for global markets. Your client has proposed to start a
project with the sterile disposable hypodermic syringes with
needles — for single-dose hypodermic injection (Fig. 1.1).
To begin with, your client has suggested designing and
manufacturing the products for the US and EU markets and,
if possible, extend the market to China in future.
Figure 1.1 Various sizes of hypodermic syringes.

Task 1: Classification
Your first task is to brief your management about the product
classifications of the device. For more details, see Chapter 14,
“Medical Device Classification Guide.”
Task 2: Risk Analysis

(For more details, see Chapter 16 on ISO14971.)
What are Classification rules

the US FDA applied to the product Notified body
Target Device regulation under EU medical device involvement for
market classification numbers directive CE marking?
EU
US
China
During the design phase of the device, suggest hazards for the
product that the product design team has to include in the design
input considerations.
Suggest the severity and occurrence for the suggested hazards.
Ensure that you have provided your own table and definition of
different levels of severity and occurrence.
Task 3: Risk Evaluation and Risk Control

(For more details, see Chapter 16 on ISO14971.)
You have to develop a risk graph (group for risk regions and
decide the risk acceptability) and risk matrix (put all the above
risks in your device).
Implement risk control measures for all of your hazards.
After all risk control measures have been implemented and
verified, the manufacturer shall decide whether the overall
residual risk posed by the medical device is acceptable using
the criteria defined in the risk management plan.
Task 4: Medical Device Registration Submission

Prepare a medical device registration submission to your competent
authority.
References 5
For example, the student will represent the company to be the

local responsible person in Hong Kong to submit an application
for listing this product to the Medical Device Division (MDD),
Department of Health in Hong Kong. The student will download the
appropriate application form from the MDD website http://www.
mdco.gov.hk/english/download/download.html and fill in the
application form according to the information in the registration
dossier provided. They will refer to the Overview of the Medical
Device Administrative Control System (GN-01) and all guidance
documents can be found at http://www.mdco.gov.hk/english/
mdacs/mdacs_gn/mdacs_gn.html.
A mock up label will be required to show the Special Listing
Information and provide the Essential Principles Declaration of
Conformity in the submission. The sample of Essential Principles
Declaration of Conformity is given in the Guidance Notes for Listing
Class II/III/IV Medical Devices (GN-02) under the above-mentioned
MDCO website.
1.2.2 Lifelong Learning

The above exercise is to equip students with lifelong learning
skills to handle regulatory affairs and the requirements from the
competent authority. Students should be encouraged to attend
workshops/seminars which are organized by the competent
authority, and key global (Asia-Pacific Economic Cooperation
[APEC], Regulatory Affairs Professionals Society [RAPS]) and
regional (Asian Harmonization Working Party [AHWP], Association
of Southeast Asian Nations [ASEAN]) organizations.
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2. ISO 13485 (Medical devices — Quality management systems —

Requirements for regulatory purposes).
3. ISO 14971 (Medical devices — Application of risk management to
medical devices).
4. Medical Device Division (MDD), https://www.mdd.gov.hk/en/home/
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5. Medical Device Control Office (MDCO), http://www.mdco.gov.hk/
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Ministerial Regulation of Health Republic Indonesia No. 1189/MENKES/Per/VIII/2010 .
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Japan: Medical Device Regulatory System

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Ministerial Ordinances [Online], Available: [09/24/2020];
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Certification Criteria [Online], Available: [09/24/2020];
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=2.
Approval Criteria [Online], Available: [09/24/2020];
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=3.
Notifications and Administrative Notices [Online], Available: [09/24/2020];
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of Safety and Performance of Medical Devices (STED), [Online], Available: [09/24/2020];
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Accreditation of Foreign Manufacturers [Online], Available: [09/24/2020];
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Accreditation Category [Online], Available: [09/24/2020];
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Application for Accreditation of Foreign Manufacturers [Online], Available: [09/24/2020];
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MHLW Ministerial Ordinance No. 169 in 2004 December 17. Ordinance on Standards for
Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic
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K. Mori , M. Watanabe , N. Horiuchi , A. Tamura , H. Kutsumi , The Role of the
Pharmaceuticals and Medical Devices Agency and Healthcare Professionals in Post-
Marketing Safety, Clin. J. Gastroenterol. 7, 103–107 (2014) [Online], Available: [09/24/2020];
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Safety Information Regarding Medical Devices by PMDA [Online], Available: [09/24/2020];
https://www.pmda.go.jp/english/safety/info-services/devices/0001.html.
Tamura, H. Kutsumi . Multiregional Medical Device Development: Regulatory Perspective,
Clin. J. Gastroenterol 7, 108–116 (2014) [Online], Available: [09/24/2020];
https://link.springer.com/article/10.1007/s12328-014-0478-2.
M. Krucoff , A. Tamura , Report from Co-Chairs: After Successful Japan–US HBD East 2013
Think Tank Meeting [Online], Available: [09/24/2020];
http://www.pmda.go.jp/hbd/meeting/report-think_tank_meeting13.html.
Overview of Medical Device Regulation in Malaysia

Medical Device Act 2012.
Medical Device Authority Act 2012.
Medical device Regulation 2012.
Appointment of date of coming into operation: P.U.(B)73.
Appointment of date of coming into operation: P.U.(B) 126.
Medical device (Exemption) Order 2015.
Medical device (Exemption) Order 2016.
Medical device (Declaration) Order 2017.
Medical Device (Duties and Obligations of Establishments) Regulations 2019.
Medical Device (Advertising) Regulation 2019.
Medical device (Exemption) Order 2016 (P.U.(A) 103 Gazetted on April 18, 2016.
MDA annual report 2012/2013,2014,2015,2016.
MOH Annual Report 2006,2007, 2008,2009,2010,2011,2012.
http://www.matrade.gov.my/.
Guideline for registration of drug-medical device and medical device-drug combination
products
Industry Mapping and Value Chain Analysis of Medical Devices Companies in Penang by
Lee Siu Ming, Penang Institute.
Life Sciences Cluster in Selangor (Part II: Medical Devices), Invest Selangor 2013.
https://www.mida.gov.my.
https://portal.mda.gov.my.
The Philippine Medical Device Regulatory System

Republic Act 9711: Strengthening of the FDA.
Administrative Order 2018-002.
DOH Website.
Singapore Medical Device Regulation

www.hsa.gov.sg.
www.arcion.com.
Taiwan: Medical Device Regulatory System Introduction

Division of Medical Devices and Cosmetics,
Food and Drug Administration, Ministry of Health and Welfare
Telephone: +886-2-2787-8000
Address: No. 161-2, Kunyang St., Nangang District,
Taipei City 115-61, Taiwan (R.O.C.)
Website: http://www.fda.gov.tw/EN
Thailand: Medical Device Control and Regulation

The Ministry of Public Health enacted the Medical Device Act, B.E. 2531 (1988).
The Medical Device Act, B.E. 2551 (2008).
The Medical Device Act, B.E. 2562 (2019).
The Notification of the Ministry of Public Health Re: Risk classification of Medical Devices.
The Notification of the Ministry of Public Health Re: Labeling and instruction for use of
Medical Devices.
The Notification of the Ministry of Public Health Re: Group of Licensed Medical Devices or
Licensed Medical Devices.
The Notification of the Ministry of Public Health Re: Group of Notified Medical Devices or
Notified Medical Devices.
Notification of the Ministry of Public Health Re: Rules, procedures and conditions for
preparing the malfunction report of medical device or adverse event that occur to consumers
and field safety corrective actions reports.
Thailand Races Ahead as Global Healthcare Hub, Investors bet on medical device market as
health tourism surges, Thailand Board of Investment (Bol).
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Thailand industry outlook 2019–2021: MEDICAL DEVICES, Krungsri Research.
Regulatory Strategy: An Overview

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An Overview of the Herbal Product Regulatory Classification in Asia

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Medical Regulatory Affairs

Medical Regulatory Affairs

British Library Cataloguing-in-Publication Data

Medical Regulatory Affairs: An International Handbook for Medical

For photocopying of material in this volume, please pay a copying fee

ISBN 978-981-4877-86-2 (Hardcover)

1. How to Train University Students in Regulatory Affairs

3. The Role of the Asia Regulatory Affairs Team in Relation

4. Commercial Sense and What It Means for a Regulatory

4.1 Know the Basics 28

5. Market Strategic Challenges for Medical Device

5.1 Strategic Changes 38

5.1.1 Product Design and Innovation 38

5.5.4 Learning When to Delegate and When

6. Regulatory Affairs as a Business Partner 59

7. Introduction to Regulatory Affairs Professionals’ Roles 63

8. What It Means to Be a Medtech Regulatory Journalist 67

9. Accelerating Access to in vitro Diagnostics: Urgent

10. Regulatory Specialists in Medical Devices in Europe:

10.1 The European MedTech Environment 85

Part 2: Medical Device Safety and Related ISO Standards

11. Biomedical Devices: Overview 95

11.1 Historic Aspect of Medical Devices 95

11.7 Vascular Disease 104

12. Labeling, Label, and Language: A Truly Global Matter 109

12.1 Introduction 109

13. Regulatory Affairs for Medical Device Clinical Trials

13.1 Introduction 123

14. Medical Device Classification Guide 145

14.1 How to Carry Out Medical Device Classification 145

15. ISO 13485:2016: Medical Devices—Quality

15.1 Introduction 169

15.13 Resource Management 180

16. ISO 14971: Application of Risk Management to

16.1 Introduction 191

16.4 Conclusion 200

17. Medical Devices—IEC International Standards and

17.1 Introduction 209

18. Good Submission Practice 217

18.1 Preamble 217

18.5.2Communication within Applicants’

Part 3: Medical Device Regulatory System in the United States,

19. United States Medical Device Regulatory Framework 237

19.1 Introduction 237

19.5.10 User Fees 252

20. Regulation of Combination Products in the United

20.1 What Products Are Considered Combination

21. European Union Medical Device Regulatory System 273

21.1 Glossary of Terms 273

21.18 CE Mark Certificate and Declaration of

22. Regulation of Combination Products in the European

22.1 Introduction: Legal Basis 321

22.4.1 Examples of Devices Incorporating an

23. Medical Device Regulatory Affairs in Latin America 335

23.1 Introduction 335

23.4 Argentina and Brazil Medical Device System 342

23.5.4.4 Timeline 356

24. Saudi Arabia: Medical Device Regulation System 363

24.1 Introduction 363