Medical regulatory affairs: an international handbook for medical devices and healthcare products
- 3rd
- Singapore Jenny Stanford Publishing 2022
- xxxix, 765 p.
Table of Contents:
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
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.