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, some notified bodies would only accept their own template as part of a CE certification; some would accept a ... A quality system implemented on the basis of the ISO 13485  standard gives a presumption of conformity with theanbsp;...
|Title||:||Handbook of Medical Device Regulatory Affairs in Asia|
|Author||:||Jack Wong, Raymond Tong Kaiyu|
|Publisher||:||CRC Press - 2013-03-27|