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. In this free webinar, we will examine current medical device registration requirements in Brazil and recent regulatory changes.
WHAT YOU WILL LEARN:
• Overview of recent regulatory changes and current ANVISA registration requirements for medical devices
• Brazil Registration Holder requirements and registration transfers
• Brazil GMP requirements and MDSAP option
• New INMETRO compliance rules and deadlines
• Clinical data requirements for higher risk devices
• ANVISA review timelines and expedited registration routes
ABOUT THE PRESENTER:
Ann Marie Boullie has over 10 years of experience in the medical device industry, with expertise in regulatory requirements and strategy in major Latin American and Asian markets. As Global Operations Manager, Ann Marie oversees Emergo’s project management team worldwide, and has operational oversite for offices such as Brazil, Mexico, the Netherlands and more. She has helped medical device clients register their products with regulators in Brazil, Mexico, Russia, Korea, and Japan since joining Emergo in 2006.