Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

Jack Wong, Raymond Tong

April 20, 2018 by Pan Stanford
Reference - 620 Pages - 102 B/W Illustrations
ISBN 9789814774314 - CAT# K377373

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Features

  • First handbook in the market to cover regulatory affairs in Asia.
  • This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application.
  • Experts from influential international regulatory bodies have contributed to the book.

Summary

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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