With a focus on Asian countries, this handbook covers medical device regulatory systems in different regions, 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 provide readers with a better understanding of regulatory affairs. With contributions from authors working with regulatory bodies around the world, the handbook explains the basics of the Asian market and how to ...
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With a focus on Asian countries, this handbook covers medical device regulatory systems in different regions, 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 provide readers with a better understanding of regulatory affairs. With contributions from authors working with regulatory bodies around the world, the handbook explains the basics of the Asian market and how to best access it. It also guides product developers through the global regulatory environment.
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Add this copy of Handbook of Medical Device Regulatory Affairs in Asia to cart. $76.32, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Newport Coast, CA, UNITED STATES, published 2013 by Jenny Stanford Publishing.
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