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• Published on: 1998-01-01
• Binding: Paperback

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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.

• Sales Rank: #1785030 in Books
• Brand: Brand: Pan Stanford Publishing
• Published on: 2013-03-27
• Original language: English
• Number of items: 1
• Dimensions: 9.40" h x 1.40" w x 6.20" l, 2.05 pounds
• Binding: Hardcover
• 616 pages

Features

• Used Book in Good Condition

Review

"This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility."
―Swee-Hin Teoh, PhD, BEng (1st Hon.), Professor in Bioengineering, Nanyang Technology University, Singapore

"While much has been written about US and European medical device regulations, the Asian regulatory picture has remained clouded for most people. This book is an excellent reference for understanding what is required to bring medical devices to market under the many different regulatory systems in this important region. It is a useful tool as companies and innovators are increasingly looking to Asia as not only a new market for existing products but a launching pad for new technologies."
―Mark Holmes, Terumo BCT, Inc., USA

"This is a very interesting book for biomedical engineering students and medical engineers and an important reference for regulatory affairs professionals. The chapters on quality management systems, such as ISO 13485 and ISO 14971, clinical trial guidelines, medical device classification guide, and the formation of the Asian Harmonization Working Party are well written in plain language."
―Dr. Kwok-kwan Chan, Hospital Authority, Hong Kong, Chairman in Biomedical Division (2012–13), Hong Kong Institution of Engineers

"[It] provides extensive information about the medical device regulatory environment in Asia and the Middle East. In addition to overviews of 16 countries, it discusses medical device classification, ISO 13485 and ISO 14971 quality standards, affordable access, medical device harmonization initiatives in Asia, and other topics of both regional and global interest. The second half of the book reviews the regulatory systems for the following countries: Australia, China, Hong Kong, India, Indonesia, Japan, Jordan, Republic of Korea, Malaysia, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, UAE and Vietnam."
―Norman M. Goldfarb, Managing Director, First Clinical Research in Journal of Clinical Research Best Practices

About the Author

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.

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It will be an excellent resources for American or other foreign investor to gain ...
By bill0610
The book covers all the essentials of regulatory affair approval targeted to Asia. It will be an excellent resources for American or other foreign investor to gain an insight in the regulatory environment in Asia. The books are well organized and worth reading!

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• Published on: 2002-01-08
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• Original language: English
• Number of items: 1
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• Published on: 1800
• Binding: Hardcover

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• Sales Rank: #5292378 in Books
• Published on: 1996
• Number of items: 1
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The genius of India, said Jawaharlal Nehru, consists of synthesis. This book, a broad survey of Indian history and culture from the Third Millennium B,C. to the 17th Century A.D., bears witness to the keenness of Nehru's generalization. In words and pictures, this book shows how the synthesizing process flowered into a varied and creative civilization.

• Sales Rank: #2348734 in Books
• Published on: 1968
• Number of items: 2
• Binding: Hardcover
• 192 pages

Most helpful customer reviews

0 of 1 people found the following review helpful.
Missing Pages
By Thomas C. Quinn
The book is fine, but several pages were missing.

3 of 3 people found the following review helpful.
The best introduction to India I've ever read
By ealovitt
I've read many books on India, all very interesting, but I wish I'd read this book first. It grounds the reader in the physical and geographical realities of the Indian landscape, all the while exploring the roots of Indian culture. The maps that accompany the text are invaluable. It took this book to make me realize that Delhi is not a port city, but is located on the high middle plateau, not far from the mountains that define India's northern border. The ancient cities of Mohenjo Daro and Harappa are closer to Kandahar and Kabul than they are to Calcutta.

Geography is destiny on the subcontinent of India. It could be argued that even the caste system developed from the complexities of its geography. Invaders had to pass through its high mountain passes to the north, or come from the sea. Once settled, their descendents were trapped in their own corner of India by her mountains, deserts, and rivers, and the population of the subcontinent splintered into a thousand different cultures, and eventually, castes. The author states that "in India--perhaps because an enormous number of dissimilar peoples had to find a way to live together--separate coexistence, not merger, became the clue to survival."

This book begins with the civilizations of the Indus Valley in the Second Millennium B.C. and ends with the decline of the Mughal Empire and the establishment of European trading colonies in the 18th century A.D. The development of Hinduism and its influence on Islam (and vice versa) is an ongoing theme throughout this book. The enormous pomp and splendor of the emperor's court is balanced against the search for enlightenment.

"By an odd coincidence in history, the Sixth Century B.C. was a century of remarkable intellectual discovery for nearly every ancient civilization." India became a center of religious ferment out of which both Jainism and Buddhism came into existence.

In spite of the emphasis on culture and religion, the historical thread is not neglected and comes alive through the men who managed to unite the different subcultures of India. From the time of the Mauryas, who created India's first great empire in the Third Century B.C. through the Mughal dynasty, founded by Babur in the Sixteenth Century A.D., the text and splendid illustrations of this book tell the story of politics and society in historic India.

I don't think we Westerners can find a better introduction to this mysterious subcontinent. I am definitely going to search out more books in this Time-Life series of the "Great Ages of Man."

0 of 8 people found the following review helpful.
Historic India-Great Ages of Man
By Baldscout
Though I haven't read it yet, just completing the series for my library. I found it in great condition, Thanks

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• Sales Rank: #362990 in Books
• Published on: 2003-03-28
• Binding: Paperback

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