Asian Medical Device Laws and Regulations: China, Hong Kong, Japan and Korea

This training on Asian medical device regulations will discuss the regulatory framework for medical devices in China, Hong Kong, Japan and Korea. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these Asian countries.

Regulatory affairs,Clinical affairs,Quality assurance, quality control, and quality systems

Dr. David Lim, Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences (A Luminex Company). In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm, www.RegulatoryDoctor.com, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals. Regulatory Doctor provides Practical, Actionable and Sustainable/strategic Solutions in an Integrated, Thorough (PASS-IT) manner for all aspects of global regulatory, quality, clinical and compliance matters.

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