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  • Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia

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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.
Lieferbar in ca. 10-20 Arbeitstagen

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190,00 CHF

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