Handbook of Medical Device Regulatory Affairs in Asia

Second Edition

Nonfiction, Health & Well Being, Medical, Medical Science, Biotechnology, Reference, Administration
Cover of the book Handbook of Medical Device Regulatory Affairs in Asia by , Jenny Stanford Publishing
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Author: ISBN: 9780429996764
Publisher: Jenny Stanford Publishing Publication: March 28, 2018
Imprint: Jenny Stanford Publishing Language: English
Author:
ISBN: 9780429996764
Publisher: Jenny Stanford Publishing
Publication: March 28, 2018
Imprint: Jenny Stanford Publishing
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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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