Medical Regulatory Affairs: An International Ha, Wong, Tong..

Jenny Stanford Publishing > CRC Press

Medical Regulatory AffairsAn International Handbook for Medical Devices and Healthcare Products\nAuthor(s): Jack Wong, Raymond Tong\nFormat: Hardback\nPublisher: Jenny Stanford Publishing, Singapore\nImprint: Jenny Stanford Publishing\nISBN-13: 9789814877862, 978-9814877862\nSynopsis\nThis 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 th.