Medical Regulatory Affairs : An International Handbook for Medical Devices and Healthcare Products

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.

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Perspectives on the Skill The Role of the Asia Regulatory Affairs Team in Relation to Commercial Sense and What It Means for a Regulatory Manager Market Strategic Challenges for Medical Device AsiaPacific Regulatory Affairs as a Business Partner Urgent Need for Increasing Medical DevicesIEC International Standards and Conformity Good Submission Practice United States Medical Device Regulatory Framework Regulation of Combination Products in the United States European Union Medical Device Regulatory System Regulation of Combination Products in the European Union Medical Device Regulatory Affairs in Latin America An Overview Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific Medical Device Classification Guide 2016 Medical Devices Quality Management Systems Application of Risk Management to Medical Devices Medical Device Regulatory System A Truly Global Matter

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Об авторе (2022)

Jack Wong is the founder of the Asia Regulatory Professionals Association (ARPA, www.ARPAedu.com). He has more than 25 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia with good knowledge in the field of medical devices, pharmaceuticals, nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007. He teaches regulatory program in more than 10 universities in Asia and is also active in ASEAN, APEC, ISO, and WHO projects.

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 of the ARPA Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association. He has developed new regulatory courses in 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., Hand of Hope), functional electrical stimulation, augmented reality for stroke rehabilitation, cognitive training, EEG, and MRI. 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).

Библиографические данные

Название Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products
Редакторы Jack Wong , Raymond K. Y. Tong
Издание: 3, иллюстрированное
Издатель CRC Press, 2022
ISBN 1000440532, 9781000440539
Количество страниц Всего страниц: 806
  
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