Description: Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong, Raymond Tong Kaiyu 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs. With contributions from authors working with regulatory bodies around the world, the handbook provides a better understanding of the Asian market and how to access it. It guides product developers through the global regulatory environment. 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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects. Author Biography Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA) and the Asia GRP (Good Regulatory Practice) Research Centre. He has more than 18 years of experience in regulatory affairs, clinical trials, and pharmacovigilence in Asia and possesses good knowledge of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007. Details ISBN 9814411213 ISBN-13 9789814411219 Title Handbook of Medical Device Regulatory Affairs in Asia Author Jack Wong, Raymond Tong Kaiyu Format Hardcover Year 2013 Pages 616 Publisher Pan Stanford Publishing Pte Ltd GE_Item_ID:139839375; 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: 144.25 USD
Location: Fairfield, Ohio
End Time: 2025-01-06T03:18:11.000Z
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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: 9789814411219
Book Title: Handbook of Medical Device Regulatory Affairs in Asia
Number of Pages: 616 Pages
Language: English
Publication Name: Handbook of Medical Device Regulatory Affairs in Asia
Publisher: Pan Stanford Publishing
Item Height: 1.5 in
Publication Year: 2013
Subject: Administration, Health Care Delivery, Instruments & Supplies
Item Weight: 33.7 Oz
Type: Textbook
Item Length: 9.3 in
Author: Raymond Tong Kaiyu
Subject Area: Medical
Item Width: 6.3 in
Format: Hardcover