Medical Regulatory Affairs An International Handbook for Medical Devices and Healthcare Products (Fourth Edition)

Preface
1. How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth in the Artificial Intelligence Era
Raymond K. Y. Tong and Orin Chisholm
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, Neil Lesser, and Orin Chisholm
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)
May Ng, Julie Dao, and Al Low
6. A Regulatory Career in Asia
Ambrose Chan
7. Coaching and Leadership Skills for Regulatory Affairs
Donald Wing Kit Chong
8. Navigating Career Paths and Excelling in Regulatory Affairs
Mylene Isler
9. Accelerating Access to in vitro Diagnostics: An Update
Rosanna W. Peeling, David Heymann, and Noah Fongwen
10. Chemistry, Manufacturing, and Controls for Synthetic Oligonucleotide Therapeutics
Chengchen Duan, and Bill Wong
11. Labeling, Label, and Language: A Truly Global Matter
Evangeline D. Loh and Jaap L. Laufer
12. Medical Device Clinical Trials in Asia Pacific: Regulatory Framework in the Asia Pacific Region
Sherry Wang Xueying
13. ISO 13485: 2016—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
Gert Bos and Timothy Joiner
14. ISO 14971: Application of Risk Management to Medical Devices
Tony Chan and Raymond K. Y. Tong
15. Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance
Gabriela Ehrlich
16. Good Submission Practice
Shinji Hatakeyama and Isao Sasaki
17. United States Medical Device Regulatory Framework
Joshua Silverstein
18. Regulation of Combination Products in the United States
Stephanie Shapley and Annette Marthaler
19. European Union Medical Device Regulatory System
Arkan Zwick and Gert W. Bos
20. Regulation of Combination Products in the European Union
Gert Bos and Bianca Lutters
21. Saudi Arabia: Medical Device Regulation System
Ali Aldalaan
22. Australian Medical Device Regulatory Framework: An Overview
Dr Elaine Blair
23. China: Medical Device Regulatory System
Jack Wong
24. Hong Kong: Medical Device Regulatory System
Carmen Ling Sephton and Jack Wong
25. India: Medical Device Regulatory System
Sumati Randeo
26. Indonesia: Medical Device Regulatory System
James Chan
27. Japan: Overview of Medical Device Regulation
Atsushi Tamura
28. Korea: Medical Device Regulatory System
Young Kim, Hyejin Moon, Hyejin Kim, and Eunji Lee
29. Overview of Medical Device Regulation in Malaysia
Salbiah Yaakop
30. The Philippine Medical Device Regulatory System
Rhoel Laderas
31. Singapore Medical Device Regulation
May Ng, Ray Soh, Kah Suan, Trish, Beatrice, Enna Lam, and Wong Tee Wee
32. Taiwan: Medical Device Regulatory System Introduction
Pei-Weng Tu
33. Thailand: Medical Device Control and Regulation
Kanokorn Pulsiri
34. Vietnam
Doan Quang Minh
35. Leading the New Normal by Accelerating Digital Transformation
Virginia Chan
36. Learning of Other Regulatory System for Medical Device Sector: Herbal Product Regulatory Classification in Asia and General Guidelines for Health Product Development
Jacob Cheong
37. Learning of Other Regulatory System for Medical Device Sector: Health Supplements—Singapore
Srilatha Sreepathy and A. V. Rukmini
38. Learning of Other Regulatory System for Medical Device Sector: Global Health Supplement Regulations
Benny Chi-Wai Lee
39. The Trend to Watch: Real-World Data and Real-World Evidence
Donald Wing Kit Chong
40. Prescription-to-OTC Switch: An Overview
Donald Wing Kit Chong
41. Emerging Evidence-Based Longevity Medicine and Products’ Regulatory Affairs
Yuan Huang
42. Enterprise Risk Management: A Holistic Guide for Navigating Regulatory Affairs with ERM
Roland H. T. Teo
43. Technology and Digital Solutions
Terence Tan
44. Medtech Start-Up: Journey to First Product Approval
Enna Lam, Shaun Kho, Kai Li, Trish, Wong Tee Wee, and May Ng
45. Digital Transformation of Healthcare and Venture Capital’s Role in It
Mark Wang
46. A Former FDA Investigator’s Views on Compliance with the Medical Device Regulations
Ken Miles
47. Bridging the Gap: The Journey of Healthtech Startups from Laboratory to Market in Singapore and Beyond
Jiah Shin Chin and Jason Kow
48. MedTech Start-Ups: A Possible Strategy for Fast Market Approval
Fabio Cirillo
49. Role of Venture Capital in Healthcare Regulations
Alvin Tay Zhi Jiang and Nikki van Teijlingen Bakker
50. Startup Regulatory at a Glance
Olivia Lee
Index

Biography

Jack Wong brings over 26 years of experience in the pharmaceutical and MedTech sectors as the founder of the Asia Regulatory Professionals Association (ARPA), which has more than 7,600 members, and as the CEO of RNAscence, a biotech startup that originated from Nanyang Technological University and the National Skin Centre in Singapore. He serves as an adjunct professor and lecturer at several prestigious institutions, including the Chinese University of Hong Kong, National University of Singapore, and Tohoku University in Japan.

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, the ARPA Hong Kong Academy; and honorary advisor, 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 (e.g., XoMuscle, Hopebotics, Hand of Hope), functional electrical stimulation, augmented reality for stroke rehabilitation, brain–computer interface (BCI), and MRI. His commitment to fostering creativity and engagement among students has resulted in numerous accolades, including the Best Teacher Award in 2021 and University Education Award in 2022, recognition as one of the Top 10 Global Ageing Influencers, fellow of the American Institute for Medical and Biological Engineering (AIMBE) College in 2022, and awardee of the 2013 Ten Outstanding Young Persons, Hong Kong. He has successfully established Hong Kong’s first Biomedical Engineering Department and developed several key courses that emphasize practical application, innovation, and regulatory processes in the biomedical field.