Understanding the Brazilian Regulatory Environment for Medical Devices
Duration : 60 Minutes
Claudia De Lucca Mano,
With a law office in Sao Paulo, Brazil, since 1994, Claudia Thereza de Lucca Mano is a practicing attorney and consultant, who specializes on Brazilian regulatory affairs affecting health, pharmaceuticals, cosmetics, nutrition, medical devices, etc.
She is registered with the Sao Paulo Read more
The Brazilian Health Surveillance Agency (ANVISA) was created in 1999 and it is the Entity responsible for regulating medical devices marketed in Brazil. ANVISA is also in charge
Course 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
Course Outline:
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.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Submissions
• Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment
• 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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