3rd Edition
Medical Regulatory Affairs An International Handbook for Medical Devices and Healthcare Products
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.
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
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).
