TY  - BOOK
AU  - EDI BY Jack Wong
AU  - Wong,Jack
AU  - Tong,Raymond
ED  - Taylor & Francis eBooks A-Z
TI  - Handbook of medical device regulatory affairs in Asia 
AV  - R856.6 .H36 2018
U1  - 610.284 2ND EDI
PY  - 2018///]
CY  - Singapore
PB  - Pan Stanford Publishing
KW  - Equipment and Supplies
KW  - standards
KW  - Device Approval
KW  - Equipment Safety
KW  - Government Regulation
KW  - Asia
N1  - Includes bibliographical references and index; Access may be restricted to institutions with a site license
N2  - "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."--Provided by publisher
UR  - http://GW2JH3XR2C.search.serialssolutions.com/?sid=sersol&SS_jc=TC0002040126&title=Handbook%20of%20medical%20device%20regulatory%20affairs%20in%20Asia
ER  -