Medical Regulatory Affairs : An International Handbook for Medical Devices and Healthcare Products PDF
Edited by Jack Wong, Raymond Tong
Description
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.
Information
-
Download - Immediately Available
- Format:PDF
- Pages:806 pages
- Publisher:Jenny Stanford Publishing
- Publication Date:26/01/2022
- Category:
- ISBN:9781000440515
Information
-
Download - Immediately Available
- Format:PDF
- Pages:806 pages
- Publisher:Jenny Stanford Publishing
- Publication Date:26/01/2022
- Category:
- ISBN:9781000440515
