Handbook of Medical Device Regulatory Affairs in Asia (Second Edition) View Front MatterView Back Matter

Handbook of Medical Device Regulatory Affairs in Asia (Second Edition)

edited by Jack Wong and Raymond Kai Yu Tong

“This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility.”

Prof. Swee-Hin Teoh, Nanyang Technology University, Singapore
  • Format: Hardcover
  • ISBN: 9789814774314
  • Subject: General Medical Sciences
  • Published: April 2018
  • Pages: 620

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 the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority (SFDA), Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, and academics and students will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

About the Editors

Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA). He has more than 20 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia and possesses good knowledge in the field of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the First Asia Regulatory Affairs Certificate course in 2007 and has been teaching at more than 10 universities.
Raymond Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair of the Hong Kong Local Responsible Person Panel and the ARPA-Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association. He has developed new regulatory courses at the Chinese University of Hong Kong on “Medical Device Regulatory Affairs and Intellectual Property” and “Global Medical Device Regulatory Affairs.” Prof. Tong’s research interests include rehabilitation robotics, functional electrical stimulation, magnetic resonance imaging, electroencephalography, and stroke rat model. His inventions have received the Ten Outstanding Young Persons in Hong Kong Award (2013), HKIE Innovation Award for Young Members (2008), five gold awards in international invention exhibitions in China (2004), Belgium (2007), Germany (2010), and Switzerland (2012, 2016), Hong Kong ICT Award (2012, 2017), and Hong Kong Award for Industry (2003).