3rd Edition

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

Edited By Jack Wong, Raymond Tong Copyright 2022
    806 Pages 110 B/W Illustrations
    by Jenny Stanford Publishing

    806 Pages 110 B/W Illustrations
    by Jenny Stanford Publishing

    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.

    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 


    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).