Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products

ISBN-13: 9789814877862 / Angielski / Twarda / 2022 / 766 str.

Jack Wong; Raymond Tong

Opis

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application.

Spis treści

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