Handbook of Medical Device Regulatory Affairs in Asia (e-bog) af -
Tong, Raymond K. Y. (redaktør)

Handbook of Medical Device Regulatory Affairs in Asia e-bog

1094,57 DKK (inkl. moms 1368,21 DKK)
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 s...
E-bog 1094,57 DKK
Forfattere Tong, Raymond K. Y. (redaktør)
Udgivet 28 marts 2018
Længde 620 sider
Genrer Medicine: general issues
Sprog English
Format pdf
Beskyttelse LCP
ISBN 9780429996771
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.