India FDA 510(k) Overview
Leading India FDA 510(k) manufacturers include M/s. Meril Endo Surgery Private Limited., Auxein Medical Private Limited, Qure.Ai Technologies and 133 others.
Indian medical device manufacturers have submitted 286 FDA 510(k) notifications since 1992, with a 100% clearance rate across 136 manufacturers. India's growing presence in the FDA 510(k) dataset reflects the country's expanding manufacturing capacity, particularly in disposable devices, diagnostic equipment and in vitro diagnostics.
Active in FDA 510(k) submissions since 1992. Many India manufacturers work with FDA regulatory consultants to support U.S. market entry.