Medical Regulatory Affairs : An International Handbook for Medical Devices and Healthcare Products book cover
3rd Edition

Medical Regulatory Affairs
An International Handbook for Medical Devices and Healthcare Products




ISBN 9789814877862
Published January 27, 2022 by Jenny Stanford Publishing
806 Pages 110 B/W Illustrations

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USD $249.95

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Book Description

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.

Table of Contents

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  
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 
David Martin and Neil Lesser 
3. The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments 
Fredrik Dalborg 
4. Commercial Sense and What It Means for a Regulatory Manager or Executive 
Annie Joseph 
5. Market Strategic Challenges for Medical Device (Asia/Pacific) 
Sherwin Tan, Ki Eunyu, Kyser Tay, and David Lee 
6. Regulatory Affairs as a Business Partner 
Claudette Joyce C. Perilla 
7. Introduction to Regulatory Affairs Professionals’ Roles 
Dacia Su 
8. What It Means to Be a Medtech Regulatory Journalist 
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 
Rosanna W. Peeling, David Heymann, Noah Fongwen, Oliver Williams, Joanna Wiecek, Phil Packer, and Gabriela Juarez-Martinez 
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 
Part 2: Medical Device Safety and Related ISO Standards 
11. Biomedical Devices: Overview 
Piu Wong 
12. Labeling, Label, and Language: A Truly Global Matter   
Evangeline D. Loh and Jaap L. Laufer 
13. Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific 
Seow Li-Ping Geraldine 
14. Medical Device Classification Guide   
Patricia Teysseyre 
15. ISO 13485:2016: Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes 
Gert Bos 
16. ISO 14971: Application of Risk Management to Medical Devices 
Tony Chan and Raymond K. Y. Tong 
17. Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance 
Gabriela Ehrlich 
18. Good Submission Practice 
Shinji Hatakeyama and Isao Sasaki 
Part 3: Medical Device Regulatory System in the United States, European Union, Saudi Arabia, and Latin America 
19. United States Medical Device Regulatory Framework   
Joshua Silverstein 
20. Regulation of Combination Products in the United States 
John Barlow Weiner and Thinh X. Nguyen 
21. European Union Medical Device Regulatory System 
Arkan Zwick and Gert Bos 
22. Regulation of Combination Products in the European Union 
Gert Bos 
23. Medical Device Regulatory Affairs in Latin America   
Carolina Cera and Gladys Servia 
24. Saudi Arabia: Medical Device Regulation System 
Ali Aldalaan 
Part 4: Medical Device Regulatory System in Asia-Pacific Region 
25. Australian Medical Device Regulations: An Overview 
Petahn McKenna 
26. China: Medical Device Regulatory System 
Jack Wong 
27. Hong Kong: Medical Device Regulatory System 
Jack Wong and Linda Chan 
28. India: Medical Device Regulatory System 
Kulwant S. Saini 
29. Indonesia: Medical Device Regulatory System   
Mita Rosalina 
30. Japan: Medical Device Regulatory System   
Atsushi Tamura and Keizo Matsukawa 
31. Korea: Medical Device Regulatory System   
Young Kim, Soo Kyeong Shin, and Jamie Noh 
32. Overview of Medical Device Regulation in Malaysia   
Ir. Sasikala Devi Thangavelu 
33. The Philippine Medical Device Regulatory System   
Rhoel Laderas 
34. Singapore Medical Device Regulation 
May Ng, Ray Soh, Trish, Beatrice, Bing Kang, Yiyu, Xinyu, Ivy Lim, and Tiffany Hu 
35. Taiwan: Medical Device Regulatory System Introduction 
Pei-Weng Tu 
36. Thailand: Medical Device Control and Regulation 
Kanokorn Pulsiri, Sirinmas Katchamart, Sansanee Pinthong, and Korrapat Trisansri 
37. Vietnam 
Nguyen Minh Tuan 
Part 5: Hot Topics 
38. A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company 
Jacky Devergne 
39. Regulatory Strategy: An Overview 
Pakhi Rusia 
40. Leading the New Normal by Accelerating Digital Transformation 
Virginia Chan 
41. An Overview of the Herbal Product Regulatory Classification in Asia and General Guidelines for Health Product Development 
Jacob Cheong 
42. Overview of Health Supplements: Singapore 
Srilatha Sreepathy, Geeta Pradeep, and A. V. Rukmini 
43. International Medical Device School Experience 
Encey Yao 
44. Medtech Start-Up: Journey to First Product Approval 
Sing Wee, Joel Tan, and Trish, May Ng 
45. Digital Transformation of Healthcare and Venture Capital’s Role in It 
Mark Wang 
46. A Regulatory Career in Asia 
Ambrose Chan 
47. A Former FDA Investigator’s Views on Compliance with the Medical Device Regulations   
Ken Miles 

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Editor(s)

Biography

Jack Wong is the founder of the Asia Regulatory Professionals Association (ARPA, www.ARPAedu.com). He has more than 25 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia with good knowledge in the field of medical devices, pharmaceuticals, nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007. He teaches regulatory program in more than 10 universities in Asia and is also active in ASEAN, APEC, ISO, and WHO projects.

Raymond K. Y. Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair, the Hong Kong Local Responsible Person Panel; chair of the ARPA Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association. He has developed new regulatory courses in 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 (e.g., Hand of Hope), functional electrical stimulation, augmented reality for stroke rehabilitation, cognitive training, EEG, and MRI. 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).