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Medical Regulatory Affairs (Third Edition)
An International Handbook for Medical Devices and Healthcare Products
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 Technological University, Singapore
- Format: Hardcover
- ISBN: 9789814877862
- Subject: Business Technology
- Published: December 2021
- Pages: 806
USD $249.95
For Course Instructors: Inspection Copies
Retailers:
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, 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, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
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
Pages: 1-8
USD $34.95
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: 9-18
USD $34.95
Add to cartChapter 3
The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments
Fredrik Dalborg
Pages: 19-26
USD $34.95
Add to cartChapter 4
Commercial Sense and What It Means for a Regulatory Manager or Executive
Annie Joseph
Pages: 27-36
USD $34.95
Add to cartChapter 5
Market Strategic Challenges for Medical Device (Asia/Pacific)
Sherwin Tan, Ki Eunyu, Kyser Tay, and David Lee
Pages: 37-58
USD $34.95
Add to cartChapter 6
Regulatory Affairs as a Business Partner
Claudette Joyce C. Perilla
Pages: 59-62
USD $34.95
Add to cartChapter 7
Introduction to Regulatory Affairs Professionals’ Roles
Dacia Su
Pages: 63-66
USD $34.95
Add to cartChapter 8
What It Means to Be a Medtech Regulatory Journalist
Amanda Maxwell
Pages: 67-72
USD $34.95
Add to cartChapter 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
Rosanna W. Peeling, David Heymann, Noah Fongwen, Oliver Williams, Joanna Wiecek, Phil Packer, and Gabriela Juarez-Martinez
Pages: 73-84
USD $34.95
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: 85-94
USD $34.95
Add to cartChapter 11
Biomedical Devices: Overview
Piu Wong
Pages: 95-108
USD $34.95
Add to cartChapter 12
Labeling, Label, and Language: A Truly Global Matter
Evangeline D. Loh and Jaap L. Laufer
Pages: 109-122
USD $34.95
Add to cartChapter 13
Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific
Seow Li-Ping Geraldine
Pages: 123-144
USD $34.95
Add to cartChapter 14
Medical Device Classification Guide
Patricia Teysseyre
Pages: 145-168
USD $34.95
Add to cartChapter 15
ISO 13485:2016: Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
Gert Bos
Pages: 169-190
USD $34.95
Add to cartChapter 16
ISO 14971: Application of Risk Management to Medical Devices
Tony Chan and Raymond K. Y. Tong
Pages: 191-208
USD $34.95
Add to cartChapter 17
Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance
Gabriela Ehrlich
Pages: 209-216
USD $34.95
Add to cartChapter 18
Good Submission Practice
Shinji Hatakeyama and Isao Sasaki
Pages: 217-236
USD $34.95
Add to cartChapter 19
United States Medical Device Regulatory Framework
Joshua Silverstein
Pages: 237-262
USD $34.95
Add to cartChapter 20
Regulation of Combination Products in the United States
John Barlow Weiner and Thinh X. Nguyen
Pages: 263-272
USD $34.95
Add to cartChapter 21
European Union Medical Device Regulatory System
Arkan Zwick and Gert Bos
Pages: 273-320
USD $34.95
Add to cartChapter 22
Regulation of Combination Products in the European Union
Gert Bos
Pages: 321-334
USD $34.95
Add to cartChapter 23
Medical Device Regulatory Affairs in Latin America
Carolina Cera and Gladys Servia
Pages: 335-362
USD $34.95
Add to cartChapter 24
Saudi Arabia: Medical Device Regulation System
Ali Aldalaan
Pages: 363-386
USD $34.95
Add to cartChapter 25
Australian Medical Device Regulations: An Overview
Petahn McKenna
Pages: 387-402
USD $34.95
Add to cartChapter 26
China: Medical Device Regulatory System
Jack Wong
Pages: 403-432
USD $34.95
Add to cartChapter 27
Hong Kong: Medical Device Regulatory System
Jack Wong and Linda Chan
Pages: 433-444
USD $34.95
Add to cartChapter 28
India: Medical Device Regulatory System
Kulwant S. Saini
Pages: 445-468
USD $34.95
Add to cartChapter 29
Indonesia: Medical Device Regulatory System
Mita Rosalina
Pages: 469-490
USD $34.95
Add to cartChapter 30
Japan: Medical Device Regulatory System
Atsushi Tamura and Keizo Matsukawa
Pages: 491-534
USD $34.95
Add to cartChapter 31
Korea: Medical Device Regulatory System
Young Kim, Soo Kyeong Shin, and Jamie Noh
Pages: 535-572
USD $34.95
Add to cartChapter 32
Overview of Medical Device Regulation in Malaysia
Ir. Sasikala Devi Thangavelu
Pages: 573-600
USD $34.95
Add to cartChapter 33
The Philippine Medical Device Regulatory System
Rhoel Laderas
Pages: 601-618
USD $34.95
Add to cartChapter 34
Singapore Medical Device Regulation
May Ng, Ray Soh, Trish, Beatrice, Bing Kang, Yiyu, Xinyu, Ivy Lim, and Tiffany Hu
Pages: 619-642
USD $34.95
Add to cartChapter 35
Taiwan: Medical Device Regulatory System Introduction
Pei-Weng Tu
Pages: 643-654
USD $34.95
Add to cartChapter 36
Thailand: Medical Device Control and Regulation
Kanokorn Pulsiri, Sirinmas Katchamart, Sansanee Pinthong, and Korrapat Trisansri
Pages: 655-666
USD $34.95
Add to cartChapter 37
Vietnam
Nguyen Minh Tuan
Pages: 667-676
USD $34.95
Add to cartChapter 38
A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company
Jacky Devergne
Pages: 677-682
USD $34.95
Add to cartChapter 39
Regulatory Strategy: An Overview
Pakhi Rusia
Pages: 683-692
USD $34.95
Add to cartChapter 40
Leading the New Normal by Accelerating Digital Transformation
Virginia Chan
Pages: 693-700
USD $34.95
Add to cartChapter 41
An Overview of the Herbal Product Regulatory Classification in Asia and General Guidelines for Health Product Development
Jacob Cheong
Pages: 701-706
USD $34.95
Add to cartChapter 42
Overview of Health Supplements: Singapore
Srilatha Sreepathy, Geeta Pradeep, and A. V. Rukmini
Pages: 707-718
USD $34.95
Add to cartChapter 43
International Medical Device School Experience
Encey Yao
Pages: 719-722
USD $34.95
Add to cartChapter 44
Medtech Start-Up: Journey to First Product Approval
Sing Wee, Joel Tan, and Trish, May Ng
Pages: 723-728
USD $34.95
Add to cartChapter 45
Digital Transformation of Healthcare and Venture Capital’s Role in It
Mark Wang
Pages: 729-736
USD $34.95
Add to cartChapter 46
A Regulatory Career in Asia
Ambrose Chan
Pages: 737-742
USD $34.95
Add to cartChapter 47
A Former FDA Investigator’s Views on Compliance with the Medical Device Regulations
Ken Miles
Pages: 743-750
USD $34.95
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 Technological University, Singapore
“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