Regulatory Considerations for Importing In Vitro Diagnostics Devices or Technologies from China
About the Speaker:
Dr. Hu has more than two decades of experience in medical product development and regulations, including 2 years at Becton Dickson, 6 years at GlaxoSmithKline, 2 years at Metabolon, and 11 years at the US FDA. Prior to joining Genetron Health as the Chief Medical Officer in April 2020, Dr. Hu was the Deputy Director of the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA. His team was responsible for regulating molecular oncology diagnostic products (liquid biopsy, early cancer screening, course detection, microresidual disease, etc.), companion diagnostics, gene testing, and artificial intelligence in anatomical and cytological pathology devices. Dr. Hu received 10 agency-level awards and eight center-level achievement awards at FDA. Dr. Hu received his Ph.D. degree in veterinary physiology & pharmacology and M.S. in reproductive endocrinology at The Ohio State University.
Moderator: Dr. Young Wang. NACCCA president of 2021. President, Wanda Henry LLC; Biomarker Director, AnHeart Therapeutics Inc.
Today, an increasing number of medical device companies in China are considering opportunities to market their products in the USA. To import any medical products for clinical use, the manufacturers and/or initial importers must follow a series of U.S. regulatory requirements.
In this talk, we will use in vitro diagnostics as an example to illustrate common approaches to importing medical devices from China and their relevant regulatory requirements and considerations.