UNDERSTANDING THE BRAZILIAN REGULATORY ENVIRONMENT FOR MEDICAL DEVICES

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

Contact:

Brooke Akins | Division Director, Life Science Programs
312.224.1693 | webinars@q1productions.com