9789814774314-9814774316-Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

ISBN-13: 9789814774314
ISBN-10: 9814774316
Edition: 2
Publication date: 2018
Publisher: Jenny Stanford Publishing
Format: Hardcover 654 pages
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Book details

ISBN-13: 9789814774314
ISBN-10: 9814774316
Edition: 2
Publication date: 2018
Publisher: Jenny Stanford Publishing
Format: Hardcover 654 pages

Summary

Acknowledged author wrote Handbook of Medical Device Regulatory Affairs in Asia: Second Edition comprising 654 pages back in 2018. Textbook and eTextbook are published under ISBN 9814774316 and 9789814774314. Since then Handbook of Medical Device Regulatory Affairs in Asia: Second Edition textbook was available to sell back to BooksRun online for the top buyback price or rent at the marketplace.

Description

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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