Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, 3rd Edition – FULL INSTANT DOWNLOAD | PDF DOCX EPUB

Name: Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products
Edition: 3rd Edition
ISBN-13: 9789814877862
ISBN-10: 9814877867
Addition ISBN: 9781003207696, 9781000440515, 1000440532, 9781000440539
Author(s): Jack Wong, Publisher: Jenny Stanford Publishing, Copyright: 2022
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.