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 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
3. The Role of the Asia Regulatory Affairs Team in Relation to
the Commercial Team and Other Departments
4. Commercial Sense and What It
Means for a Regulatory Manager or Executive
5. Market Strategic Challenges
for Medical Device (Asia/Pacific)
6. Regulatory Affairs as a Business Partner
7. Introduction to Regulatory Affairs Professionals Roles
8. What It Means
to Be a Medtech Regulatory Journalist
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
10.
Regulatory Specialists in Medical Devices in Europe: Meeting the Challenge of
Keeping Current in a Changing EnvironmentHow TOPRA Supports Professionals in
a Dynamic Industry Part 2: Medical Device Safety and Related ISO Standards
11. Biomedical Devices: Overview
12. Labeling, Label, and Language: A Truly
Global Matter
13. Regulatory Affairs for Medical Device Clinical Trials in
Asia Pacific
14. Medical Device Classification Guide
15. ISO 13485:2016:
Medical DevicesQuality Management SystemsRequirements for Regulatory
Purposes
16. ISO 14971: Application of Risk Management to Medical Devices
17.
Medical DevicesIEC International Standards and Conformity Assessment
Services in Support of Medical Regulation and Governance
18. Good Submission
Practice Part 3: Medical Device Regulatory System in the United States,
European Union, Saudi Arabia, and Latin America
19. United States Medical
Device Regulatory Framework
20. Regulation of Combination Products in the
United States
21. European Union Medical Device Regulatory System
22.
Regulation of Combination Products in the European Union
23. Medical Device
Regulatory Affairs in Latin America
24. Saudi Arabia: Medical Device
Regulation System Part 4: Medical Device Regulatory System in Asia-Pacific
Region
25. Australian Medical Device Regulations: An Overview
26. China:
Medical Device Regulatory System
27. Hong Kong: Medical Device Regulatory
System
28. India: Medical Device Regulatory System
29. Indonesia: Medical
Device Regulatory System
30. Japan: Medical Device Regulatory System
31.
Korea: Medical Device Regulatory System
32. Overview of Medical Device
Regulation in Malaysia
33. The Philippine Medical Device Regulatory System
34. Singapore Medical Device Regulation
35. Taiwan: Medical Device Regulatory
System Introduction
36. Thailand: Medical Device Control and Regulation
37.
Vietnam Part 5: Hot Topics
38. A Strong Regulatory Strategy Is a Competitive
Advantage to a Medical Device Company
39. Regulatory Strategy: An Overview
40. Leading the New Normal by Accelerating Digital Transformation
41. An
Overview of the Herbal Product Regulatory Classification in Asia and General
Guidelines for Health Product Development
42. Overview of Health Supplements:
Singapore
43. International Medical Device School Experience
44. Medtech
Start-Up: Journey to First Product Approval
45. Digital Transformation of
Healthcare and Venture Capitals Role in It
46. A Regulatory Career in Asia
47. A Former FDA Investigators Views on Compliance with the Medical Device
Regulations
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. Tongs 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).
