Medical Regulatory Affairs (Third Edition) View Front MatterView Back Matter

Medical Regulatory Affairs (Third Edition)

An International Handbook for Medical Devices and Healthcare Products

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 Technological University, Singapore
  • Format: Hardcover
  • ISBN: 9789814877862
  • Subject: Business Technology
  • Published: December 2021
  • Pages: 806

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.