Description: Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong, Raymond Tong Estimated delivery 3-12 business days Format Hardcover Condition Brand New 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. Publisher Description 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. 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. Author Biography Jack Wong is regulatory affairs head, Asia Pacific, at Baxter Healthcare. He has more than 20 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia with good knowledge in the field of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Raymond Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair, the Hong Kong Local Responsible Person Panel; chair of the Asia Regulatory Professional Association (ARPA)-Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association. Details ISBN 9814774316 ISBN-13 9789814774314 Title Handbook of Medical Device Regulatory Affairs in Asia Author Jack Wong, Raymond Tong Format Hardcover Year 2018 Pages 654 Edition 2nd Publisher Pan Stanford Publishing Pte Ltd GE_Item_ID:139849026; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items - you're bound to find what you want, at a price you'll love! Shipping & Delivery Times Shipping is FREE to any address in USA. Please view eBay estimated delivery times at the top of the listing. Deliveries are made by either USPS or Courier. We are unable to deliver faster than stated. International deliveries will take 1-6 weeks. NOTE: We are unable to offer combined shipping for multiple items purchased. This is because our items are shipped from different locations. Returns If you wish to return an item, please consult our Returns Policy as below: Please contact Customer Services and request "Return Authorisation" before you send your item back to us. Unauthorised returns will not be accepted. Returns must be postmarked within 4 business days of authorisation and must be in resellable condition. Returns are shipped at the customer's risk. We cannot take responsibility for items which are lost or damaged in transit. For purchases where a shipping charge was paid, there will be no refund of the original shipping charge. Additional Questions If you have any questions please feel free to Contact Us. Categories Baby Books Electronics Fashion Games Health & Beauty Home, Garden & Pets Movies Music Sports & Outdoors Toys
Price: 129.79 USD
Location: Fairfield, Ohio
End Time: 2024-12-09T03:02:30.000Z
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Restocking Fee: No
Return shipping will be paid by: Buyer
All returns accepted: Returns Accepted
Item must be returned within: 30 Days
Refund will be given as: Money Back
ISBN-13: 9789814774314
Book Title: Handbook of Medical Device Regulatory Affairs in Asia
Number of Pages: 654 Pages
Language: English
Publication Name: Handbook of Medical Device Regulatory Affairs in Asia
Publisher: Pan Stanford Publishing
Publication Year: 2018
Subject: Instruments & Supplies, General
Features: New Edition
Item Weight: 36.1 Oz
Type: Textbook
Author: Raymond Tong
Item Length: 9 in
Subject Area: Medical
Item Width: 6 in
Format: Hardcover