UNDERSTANDING THE BRAZILIAN REGULATORY ENVIRONMENT FOR MEDICAL DEVICES

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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’s regulatory risk classification system is similar to that of the previous EU MDD 93/42/EEC, and recently published some updates on Registration Renewals. 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.

  • Legislation for Medical Devices
  • Methods for determining appropriate device classification
  • Clinical Data
  • ANVISA’s GMP Certification
  • INMETRO Certification
  • Additional Requests
  • Timelines for obtaining approvals

Speaker:
Milena Vicente
Regulatory Affairs, Quality Affairs Director
CR Bard Latin America

Brooke AkinsContact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 
bakins@q1productions.com