Handbook of Medical Device Regulatory Affairs in Asia

With a focus on Asian countries, this handbook covers medical device regulatory systems in different regions, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Each chapter provides substantial background materials relevant to the particular area to provide readers with a better understanding of regulatory affairs. With contributions from authors working with regulatory bodies around the world, the handbook explains the basics of the Asian market and how to best access it. It also guides product developers through the global regulatory environment.

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.