FDA 510(k) Medical Device Manufacturers - Vietnam

Leading Vietnam FDA 510(k) manufacturers include Ever Global (Vietnam) Enterprise Corporation, Ever Growth (Vietnam) Co. , Ltd., S&S Glove Corporation and 20 others.

Vietnamese medical device manufacturers have submitted 35 FDA 510(k) notifications since 2018, with a 100% clearance rate across 23 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 2018. Many Vietnam manufacturers work with FDA regulatory consultants to support U.S. market entry.