Overview

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, 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, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects. The updated fourth edition includes specific contributions that address the needs of startups.

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Jack Wong brings over 26 years of experience in the pharmaceutical and MedTech sectors as the founder of the Asia Regulatory Professionals Association (ARPA), which has more than 7,600 members, and as the CEO of RNAscence, a biotech startup that originated from Nanyang Technological University and the National Skin Centre in Singapore. He serves as an adjunct professor and lecturer at several prestigious institutions, including the Chinese University of Hong Kong, National University of Singapore, and Tohoku University in Japan. Raymond K. Y. Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair, the Hong Kong Local Responsible Person Panel; chair, the ARPA Hong Kong Academy; and honorary advisor, 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 (e.g., XoMuscle, Hopebotics, Hand of Hope), functional electrical stimulation, augmented reality for stroke rehabilitation, brain–computer interface (BCI), and MRI. His commitment to fostering creativity and engagement among students has resulted in numerous accolades, including the Best Teacher Award in 2021 and University Education Award in 2022, recognition as one of the Top 10 Global Ageing Influencers, fellow of the American Institute for Medical and Biological Engineering (AIMBE) College in 2022, and awardee of the 2013 Ten Outstanding Young Persons, Hong Kong. He has successfully established Hong Kong’s first Biomedical Engineering Department and developed several key courses that emphasize practical application, innovation, and regulatory processes in the biomedical field.

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