Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. In this blog post, you will be able to download free PDF e-book copy of Handbook of Medical Device Regulatory Affairs in Asia PDF.
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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
Table of Contents
Below is the complete table of contents presented in Handbook of Medical Device Regulatory Affairs in Asia PDF:
1. How to Train University Students in Regulatory Affairs
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. Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Globally
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. Affordable Access to Medical Devices in Developing Countries
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. 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. Introduction of 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. Malaysia: Medical Device Regulatory System
33. Philippines: Medical Device Regulatory System and Licensing
34. Singapore: Medical Device Regulatory System
35. Taiwan: Medical Device Regulatory System
36. Thailand: Regulatory and Medical Device Control
37. Vietnam: Medical Device Regulatory System
38. A Strong Regulatory Strategy Is a Competitive Advantage to a Medical Device Company
Product Details
Below are the technical specifications of Handbook of Medical Device Regulatory Affairs in Asia PDF.
- Edition 2nd Edition
- ISBN 9814774316
- Format PDF
- Page Count 654 Pages
- Author Jack Wong, Raymond Tong
Handbook of Medical Device Regulatory Affairs in Asia PDF Free Download
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