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 1551 others.
Chinese medical device manufacturers have submitted 4,065 FDA 510(k) notifications since 2000, with a 100% clearance rate reflecting strong submission quality. China represents the second-largest non-U.S. contributor to the dataset, with 1,554 manufacturers active across imaging, diagnostics, electrotherapy and surgical device categories.
Active in FDA 510(k) submissions since 2000. Many China manufacturers work with FDA regulatory consultants to support U.S. market entry.