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Understanding the Brazilian Regulatory Environment for Medical Devices  

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Online Compliance Panel   

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Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment

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Seminar Summary:

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 for post-market surveillance. Brazil is the largest market for medical devices in South America and presents a significant challenge for regulators looking to navigate its complex and dynamic regulatory system. This webinar showcases the regulatory environment and the recent updates from ANVISA in Brazil. (see full course description)

 

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Training Course Syllabus:


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

Seminar Summary:

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 for post-market surveillance. Brazil is the largest market for medical devices in South America and presents a significant challenge for regulators looking to navigate its complex and dynamic regulatory system. This webinar showcases the regulatory environment and the recent updates from ANVISA in Brazil. (see full course description)

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