Medical Regulatory Affairs

Description

Pages:
806
Language:
English
Format:
PDF
Size:
39 MB
ISBN-10:
9814877867
ISBN-13:
978-9814877862, 9789814877862
ASIN:
B09MR4LDL7
3rd Edition

by Jack Wong (Editor), Raymond Tong (Editor)

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, and academics and students will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.