Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia

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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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.For instance, an insulin pump might be used by an array of users from a highly educated physician diabetologist to a semi-literate elderly person. An implantable left ventricular assist device (LVAD) may have up to four different manuals for theanbsp;...

Title:Handbook of Medical Device Regulatory Affairs in Asia
Author: Jack Wong, Raymond Tong Kaiyu
Publisher:CRC Press - 2013-03-27

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