Thailand FDA 510(k) Overview
Leading Thailand FDA 510(k) manufacturers include Siam Sempermed Corp., Ltd., Sri Trang Gloves (Thailand) Public Company Limited, Suretex Limited and 29 others.
Thai medical device manufacturers have submitted 91 FDA 510(k) notifications since 1989, achieving a 100% clearance rate across 32 manufacturers. Thailand's medtech sector is particularly active in medical gloves, disposable devices and examination equipment, reflecting the country's established position as a major global supplier of rubber-based medical products.
Active in FDA 510(k) submissions since 1989. Many Thailand manufacturers work with FDA regulatory consultants to support U.S. market entry.