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 47 others.

Brazilian medical device manufacturers have submitted 142 FDA 510(k) notifications since 2018, with a 99.3% clearance rate across 50 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 2018. Many Brazil manufacturers work with FDA regulatory consultants to support U.S. market entry.