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Handbook of Medical Device Regulatory Affairs in Asia (Second Edition)
edited by Jack Wong and Raymond Kai Yu Tong
“This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility.”
Prof. Swee-Hin Teoh, Nanyang Technology University, Singapore
- Format: eBook
- ISBN: 9780429504396
- Subject: General Medical Sciences
- Published: November -0001
For Course Instructors: Inspection Copies
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority (SFDA), Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, and academics and students will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
About the Editors
Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA). He has more than 20 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia and possesses good knowledge in the field of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the First Asia Regulatory Affairs Certificate course in 2007 and has been teaching at more than 10 universities.
Raymond Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair of the Hong Kong Local Responsible Person Panel and the ARPA-Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association. He has developed new regulatory courses at the Chinese University of Hong Kong on “Medical Device Regulatory Affairs and Intellectual Property” and “Global Medical Device Regulatory Affairs.” Prof. Tong’s research interests include rehabilitation robotics, functional electrical stimulation, magnetic resonance imaging, electroencephalography, and stroke rat model. His inventions have received the Ten Outstanding Young Persons in Hong Kong Award (2013), HKIE Innovation Award for Young Members (2008), five gold awards in international invention exhibitions in China (2004), Belgium (2007), Germany (2010), and Switzerland (2012, 2016), Hong Kong ICT Award (2012, 2017), and Hong Kong Award for Industry (2003).
Chapter 1
How to Train University Students in Regulatory Affairs
Raymond K. Y. Tong
Pages: 1
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Add to cartChapter 2
The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals
David Martin and Neil Lesser
Pages: 7
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Add to cartChapter 3
The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments
Fredrik Dalborg
Pages: 17
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Add to cartChapter 4
Commercial Sense and What It Means for a Regulatory Manager or Executive
Annie Joseph
Pages: 25
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Add to cartChapter 5
Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Globally
May Ng, Martin Ng, Ray Soh, Fadzlon Yunos, and Stephen Hsu
Pages: 35
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Add to cartChapter 6
Regulatory Affairs as a Business Partner
Claudette Joyce C. Perilla
Pages: 43
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Add to cartChapter 7
Introduction to Regulatory Affairs Professionals’ Roles
Dacia Su
Pages: 47
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Add to cartChapter 8
What It Means to Be a Medtech Regulatory Journalist
Amanda Maxwell
Pages: 51
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Add to cartChapter 9
Affordable Access to Medical Devices in Developing Countries
Rosanna W. Peeling and Tikki Pang
Pages: 57
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Add to cartChapter 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
Lynda J. Wight
Pages: 69
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Add to cartChapter 11
Biomedical Devices: Overview
Piu Wong
Pages: 79
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Add to cartChapter 12
Labeling, Label, and Language: A Truly Global Matter
Evangeline D. Loh and Jaap L. Laufer
Pages: 93
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Add to cartChapter 13
Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific
Seow Li-Ping Geraldine
Pages: 107
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Add to cartChapter 14
Medical Device Classification Guide
Patricia Teysseyre
Pages: 129
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Add to cartChapter 15
ISO 13485:2003/2016—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
Gert Bos
Pages: 153
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Add to cartChapter 16
ISO 14971: Application of Risk Management to Medical Devices
Tony Chan and Raymond K. Y. Tong
Pages: 175
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Add to cartChapter 17
Medical Devices: IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance
Gabriela Ehrlich
Pages: 193
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Add to cartChapter 18
Introduction of Good Submission Practice
Isao Sasaki
Pages: 201
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Add to cartChapter 19
United States Medical Device Regulatory Framework
James Bertram
Pages: 217
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Add to cartChapter 20
Regulation of Combination Products in the United States
John Barlow Weiner and Thinh X. Nguyen
Pages: 239
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Add to cartChapter 21
European Union: Medical Device Regulatory System
Arkan Zwick
Pages: 249
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Regulation of Combination Products in the European Union
Janine Jamieson and Elizabeth Baker
Pages: 299
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Add to cartChapter 23
Medical Device Regulatory Affairs in Latin America
Carolina Cera and Gladys Servia
Pages: 311
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Saudi Arabia: Medical Device Regulation System
Ali Aldalaan
Pages: 339
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Add to cartChapter 25
Australian Medical Device Regulations: An Overview
Petahn McKenna
Pages: 361
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Add to cartChapter 26
China: Medical Device Regulatory System
Jean Zhang
Pages: 377
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Add to cartChapter 27
Hong Kong: Medical Device Regulatory System
Jack Wong and Linda Chan
Pages: 401
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Add to cartChapter 28
India: Medical Device Regulatory System
Kulwant S. Saini
Pages: 413
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Add to cartChapter 29
Indonesia: Medical Device Regulatory System
Mita Rosalina
Pages: 437
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Add to cartChapter 30
Japan: Medical Device Regulatory System
Atsushi Tamura
Pages: 459
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Add to cartChapter 31
Korea: Medical Device Regulatory System
Young Kim, Soo Kyeong Shin, and Jamie Noh
Pages: 475
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Add to cartChapter 32
Malaysia: Medical Device Regulatory System
Yew Siak Wah
Pages: 513
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Add to cartChapter 33
Philippines: Medical Device Regulatory System and Licensing
Mitzumi F. Duclayan, Mary Claire Cacanindin, and Jennifer Cheah
Pages: 523
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Add to cartChapter 34
Singapore: Medical Device Regulatory System
Annie Goh
Pages: 541
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Add to cartChapter 35
Taiwan: Medical Device Regulatory System
Pei-Weng Tu
Pages: 569
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Add to cartChapter 36
Thailand: Regulatory and Medical Device Control
Yuwadee Patanawong and Nachsupol Arunaramamporn
Pages: 581
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Add to cartChapter 37
Vietnam: Medical Device Regulatory System
Nguyễn Minh Tuâ´n and Le Thu Nga
Pages: 591
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Add to cartChapter 38
A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company
Jacky Devergne
Pages: 603
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Add to cartJack Wong is the founder of the Asia Regulatory Professional Association (ARPA) and the Asia GRP (Good Regulatory Practice) Research Centre. He has more than 18 years of experience in regulatory affairs, clinical trials, and pharmacovigilence in Asia and possesses good knowledge of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the firstAsia Regulatory Affairs Certificate course in 2007.
Raymond Kai-yu Tong is professor and program leader in Biomedical Engineering in the Interdisciplinary Division of Biomedical Engineering, Hong Kong Polytechnic University (PolyU), and chair of the ARPA–Hong Kong Academy. His research interests include rehabilitation robotics, Kinect-based rehabilitation software, functional electrical stimulation, and stroke rat models. Since 2004, Prof. Tong has developed new regulatory courses in PolyU on “Intellectual Property, Standards & Regulations of Medical Devices” and “Medical Devices Regulatory and Risk Management.”
Dr. Raymond Tong Kaiyu received his PhD in bioengineering from the University of Strathclyde, Glasgow, UK, in 1998. He joined the Hong Kong Polytechnic University in 1999 and the Department of Health Technology and Informatics as an associate professor in 2008. His research interests include rehabilitation robot and functional electrical stimulation system for persons who have suffered stroke. His research and innovation have received Faculty Award on Research and Scholarly Activities(FHSS, PolyU) in 2009; Grand Award from HKIE innovation awards for young members(The Hong Kong Institute of Engineers) in 2008; Gold award from Brussels Eureka 2007 (also known as the 56th World Exhibition of Innovation, Research and Industrial Innovation); Gold award from the 5th China International Invention Exhibition 2004; and Certificate of Merit in Consumer Product Design from the Hong Kong Award for Industry 2003. He teaches subjects related to bioinstrumentation, medical devices, clinical electrophysiology, medical device regulatory (FDA, ISO, MDD), and intellectual property (Patent).
“This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility.”
~Prof. Swee-Hin Teoh, Nanyang Technology University, Singapore
“While much has been written about US and European medical device regulations, the Asian regulatory picture has remained clouded for most people. This book is an excellent reference for understanding what is required to bring medical devices to market under the many different regulatory systems in this important region. It is a useful tool as companies and innovators are increasingly looking to Asia as not only a new market for existing products but a launching pad for new technologies.”
~Mark Holmes, Terumo BCT, Inc., USA
“This is a very interesting book for biomedical engineering students and medical engineers and an important reference for regulatory affairs professionals.”
~Dr. Kwok-kwan Chan, Hospital Authority, Hong Kong, Chairman in Biomedical Division (2012–13), Hong Kong Institution of Engineers