Handbook of Medical Device Regulatory Affairs in Asia

<p>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. </p><p>Handbook of Medical Device Regulatory Affairs in Asia <strong>covers medical device regulatory systems in different countries ISO standards for medical devices clinical trial and regulatory requirements and documentation for application. </strong>Government<b> </b>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.</p>