Understanding the Brazilian Regulatory Environment for Medical Devices

Duration: 60 Minutes
flat 50% off on this webinar
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.
Brazilian Medical Device Regulations
Product ID: 506563
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 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
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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 Brazilian Bar branch, and has a law degree from Pontificia Universidade Catolica, Sao Paulo, with emphasis on Collective Rights.

Ms.Claudia is the founder of congress for pharmaceutical ingredients and prescription pharmacies Pharmashare©". 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, and of the American Bar Association, Section of International Law, Committees of Foreign Legal Consultant and International Life Sciences and Health Law.
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