Medical Device Registration – Brazil ANVISA

Brazil’s medical device industry faced a number of challenges in recent years: A complex regulatory process created long delays for approvals, and a tumultuous economic and political future presented uncertainties for foreign manufacturers. However, ANVISA released numerous regulatory updates in 2016 to make Brazil a more accessible medical device market. For companies currently selling in Brazil, this also means new rules for staying in compliance with ANVISA’s requirements.

About the presenter:

Priscila Sanada, senior consultant, Emergo by UL

Priscila Sanada has over 15 years of regulatory affairs experience and is a valuable member of our consulting team in Brazil. She works on medical device consulting projects for all risk classes. Sanada’s regulatory background includes Brazil and Mexico registrations, Medical Device Registration (MDR) regulations, global regulatory strategy advising and regulatory research on markets in Latin America. In her current role, Sanada oversees Emergo by UL's senior regulatory affairs consultants in Brazil and has peer reviewed more than 500 regulatory filings and reports.