Handbook of Medical Device Regulatory Affairs in Asia

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.

Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA) and the Asia GRP (Good Regulatory Practice) Research Centre. He has more than 18 years of experience in regulatory affairs, clinical trials, and pharmacovigilence in Asia and possesses good knowledge of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007.

Introduction. Medical device safety and related ISO Standards. Harmonization of Medical Device in Asia. US and EU Regulatory System. Regulation in Asia-Pacific Countries.