Canada FDA 510(k) Overview
Leading Canada FDA 510(k) manufacturers include Orthosoft Inc. (d/b/a) Zimmer CAS, Baylis Medical Company, Inc., Bodycad Laboratories, Inc. and 205 others.
Canadian medical device manufacturers have submitted 433 FDA 510(k) notifications since 2017, with a 97.7% clearance rate. Canada's medtech sector is well-integrated with the U.S. regulatory pathway, with 201 manufacturers covering a broad range of specialties including neurology, cardiovascular and general hospital devices.
Active in FDA 510(k) submissions since 2017. Many Canada manufacturers work with FDA regulatory consultants to support U.S. market entry.