Objectives of the Presentation
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
Why Should you Attend
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. ANVISA was able to simplify procedures for less risky products, freeing Class 1 and 2 products from complex regulatory procedures such as renewal of registration every 5 years and/or GMP inspections overseas.
For companies currently selling in Brazil, this also means new rules for staying in compliance with ANVISA´s requirements. 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.
Who will Benefit
Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment and Regulatory Submissions, Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant, QA / QC Personnel, Global Supply Chain personnel, Clinical / Pharma & Device personnel, Manufacturing personnel, Global Business Development personnel, Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization will also benefit