Understanding the Brazilian Regulatory Environment for Medical Devices

1 Hour Video | Milena Vicente, CR Bard Latin America

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


Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Regulatory Submissions

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

Milena Vicente is RAQA Director for Latin America Region at CR Bard Brazil. She joined CR Bard in October 2011. In this role, she was responsible for the company startup in Brazil related to all Quality and Regulatory matters. Currently, she is responsible for strategic activities related to product registration submissions in Latin America countries, including Brazil. Before joining CR Bard, Ms. Vicente worked for Eli Lilly in Sao Paulo for 13 years, mostly in Quality Control, Quality Assurance and Regulatory. She has a specialization degree in Pharmaceutical Marketing and a Bachelor Degree in Pharmacy-Biochemistry.

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