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Handbook of Medical Device Regulatory Affairs in Asia - Second Edition (Hardcover, 2nd edition)
Loot Price: R3,418
Discovery Miles 34 180
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Handbook of Medical Device Regulatory Affairs in Asia - Second Edition (Hardcover, 2nd edition)
Expected to ship within 12 - 17 working days
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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. This handbook covers medical device regulatory
systems in different countries, ISO standards for medical devices,
clinical trial and regulatory requirements, and documentation for
application. It is the first to cover the medical device regulatory
affairs in Asia. Each chapter provides substantial background
materials relevant to the particular area to have a better
understanding of regulatory affairs.
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