Handbook of Medical Device Regulatory Affairs in Asia Handbook of Medical Device Regulatory Affairs in Asiacovers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory r
Open Library Books
| Title | : | Handbook of Medical Device Regulatory Affairs in Asia |
| Author | : | |
| Rating | : | 4.69 (562 Votes) |
| Asin | : | 9814411213 |
| Format Type | : | Hardcover |
| Number of Pages | : | 616 Pages |
| Publish Date | : | 2013-03-27 |
| Genre | : |
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 Asiacovers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Governmentbodies, 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.
Editorial : "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
This book was a tough read for me. These methods work. I purchased this product at a discounted price in exchange for a honest unbiased review.. It begins with the shout-out by the National Professional Society of Pharmacist's executive vice president urging consumers to include your pharmacist in your medical recovery team. Perhaps professional associations can buy large numbers of the reference book and make them available to their members at a discount. This book explains the termonolgy of this world in an informative, understandable way, not too clinical that it leaves you shaking your head and wondering :"huh?" If you ever had any questions about this subject, an active member of the BDSM community or have a friend or family member who is this is a MUST read for you as well as for them. A real eye opener on how plants work and how magic the world is. The book offers interesting analogies between eastern and western medicine and an extensive recommended reading list. The assessment
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