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Regulations in Brazil are a complex framework of federal, state and city rules, which requires careful navigation. 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 recently to make Brazil a more accessible medical device market. ANVISA has simplified importation regulations to ease market entry for foreign manufacturers commercializing in the country. In this webinar, Brazilian Regulatory affairs expert, Claudia
Thereza de Lucca Mano will examine current medical device registration requirements in Brazil and recent regulatory changes.
Key Learning Objectives
- Overview of recent regulatory changes and current ANVISA registration requirements for
- medical devices
- Brazil registration holder requirements and registration transfers
- Methods for determining appropriate device classification
- ANVISA�s GMP requirements and MDSAP option
- New INMETRO compliance rules
- ANVISA review timelines and expedited registration routes
- Timelines for obtaining approvals
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Claudia De Lucca Mano
Claudia is a practicing attorney and consultant, who specializes on Brazilian regulatory affairs affecting health, pharmaceuticals, cosmetics, nutrition, medical devices, etc. She is an expert on Brazil's National Agency for Sanitary Surveillance (ANVISA), also a member of Committee of Regulated Markets and Sanitary Law of Brazilian Bar.
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