Medical Regulatory Affairs

Auteur

Jack Wong has more than 26 years' experience in the pharma and medtech sector. He is the founder of the Asia Regulatory Professionals Association (ARPA) with more than 7000 members (www.ARPAedu.com), adjunct professor/lecturer at the Chinese University of Hong Kong, Hong Kong University, National University of Singapore, and Tohoku University, Japan, and CEO of RNAscence (a biotech start-up spin-off from Nanyang Technological University and National Skin Centre, Singapore; www.BioRNA.sg).

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.

Texte du rabat

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.

Contenu

Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products (Fourth Edition)