Medical Regulatory Affairs

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.

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).

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 Environment-How 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 Devices-Quality Management Systems-Requirements for Regulatory Purposes 16. ISO 14971: Application of Risk Management to Medical Devices 17. Medical Devices-IEC 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 Capital's Role in It 46. A Regulatory Career in Asia 47. A Former FDA Investigator's Views on Compliance with the Medical Device Regulations

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