China FDA 510(k) Overview
Leading China FDA 510(k) manufacturers include Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Edan Instruments, Inc., Andon Health Co, Ltd. and 2121 others.
Chinese medical device manufacturers have submitted 5,446 FDA 510(k) notifications since 1996, with a 100% clearance rate reflecting strong submission quality. China represents the second-largest non-U.S. contributor to the dataset, with 2,124 manufacturers active across imaging, diagnostics, electrotherapy and surgical device categories.
Active in FDA 510(k) submissions since 1996. Many China manufacturers work with FDA regulatory consultants to support U.S. market entry.