FDA 510(k) Medical Device Manufacturers - Brazil

Leading Brazil FDA 510(k) manufacturers include Jjgc Industria E Comercio DE Materiais Dentarios S.A., S.I.N. ? Sistema DE Implante Nacional S.A., GM Dos Reis Industria e Comercio Ltda. and 51 others.

Brazilian medical device manufacturers have submitted 158 FDA 510(k) notifications since 1997, with a 99.4% clearance rate across 54 manufacturers. Brazil's FDA-active medtech sector reflects the country's growing investment in U.S. market access, with activity in dental devices, cardiovascular equipment and diagnostic technologies.

Active in FDA 510(k) submissions since 1997. Many Brazil manufacturers work with FDA regulatory consultants to support U.S. market entry.