Vietnam FDA 510(k) Overview
Leading Vietnam FDA 510(k) manufacturers include Vietglove Corporation, Ever Global (Vietnam) Enterprise Corporation, Ever Growth (Vietnam) Co. , Ltd. and 26 others.
Vietnamese medical device manufacturers have submitted 51 FDA 510(k) notifications since 2004, with a 100% clearance rate across 29 manufacturers. Vietnam's presence in the FDA 510(k) dataset reflects the country's growing role as a medical device manufacturing base in Southeast Asia, with activity in disposable devices and diagnostic equipment.
Active in FDA 510(k) submissions since 2004. Many Vietnam manufacturers work with FDA regulatory consultants to support U.S. market entry.
Search Vietnam devices in FDA 510(k) database