Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have established new or refined existing regulatory systems. A registered product requires extensive 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, hospitals, and 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 medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to understand regulatory affairs better.
