Japan FDA 510(k) Overview
Leading Japan FDA 510(k) manufacturers include Olympus Medical Systems Corp., Canon Medical Systems Corporation, Asahi Intecc Co., Ltd. and 133 others.
Japanese medical device manufacturers have submitted 1,069 FDA 510(k) notifications since 1982, with a 100% clearance rate across 136 manufacturers. Japan's FDA-active companies reflect the country's precision manufacturing capabilities, with concentration in endoscopy systems, imaging devices, dental equipment and advanced diagnostic technologies.
Active in FDA 510(k) submissions since 1982. Many Japan manufacturers work with FDA regulatory consultants to support U.S. market entry.