Overview of the IVD regulatory landscape in Brazil

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Overview of the IVD regulatory landscape in BrazilWant to sell your IVD in Brazil? Brazil regulators made sweeping regulatory changes in 2015, especially for IVDs. In particular, they consolidated and aligned IVD regulations with international guidelines. These changes had a significant impact on IVD manufacturers and Brazilian regulators.

In this white paper, we'll discuss current ANVISA regulations for IVDs and discuss key issues to consider before entering the Brazilian market. You will learn:

  • A history of IVD regulations in Brazil
  • ANVISA's current approach to IVD regulations
  • How recent changes affected BGMP compliance issues
  • Important guidance for IVD manufacturers
  • Key differences between IMDRF guidance and ANVISA requirements
  • A guide to unforeseen challenges in this new regulatory landscape

We'll answer your biggest questions and more in this 7-page white paper.

About the Author
Ana Carolina Zidko is a Senior Regulatory Affairs Consultant in Brazil. Her areas of expertise include regulatory submissions for medical devices and IVDs in Brazil and INMETRO certifications. She holds a master’s degree in microbiology and immunology from the Universidade Federal de São Paulo (São Paulo University).