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.
Price: 199 USD
Location: Wiri
End Time: 2025-01-04T11:26:47.000Z
Shipping Cost: 0 USD
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Return shipping will be paid by: Buyer
All returns accepted: Returns Accepted
Item must be returned within: 60 Days
Refund will be given as: Money back or replacement (buyer's choice)
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EAN: 9789814877862
UPC: 9789814877862
ISBN: 9789814877862
MPN: N/A
Item Height: 4.3 cm
Number of Pages: 766 Pages
Publication Name: Medical Regulatory Affairs
Language: English
Publisher: Jenny Stanford Publishing
Publication Year: 2022
Subject: Biotechnology, Administration, General
Item Weight: 58.4 Oz
Type: Textbook
Item Length: 9 in
Subject Area: Medical
Author: Raymond K. Y. Tong
Item Width: 6 in
Format: Hardcover
