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Medical Devices

International Reliance: Medical Devices in the Tropics: Tips, Tricks and Odds for Your ANVISA Submission

Friday, May 8, 2026
11:15 - 12:15 WEST
Location: Auditorium 1
Learning Level: Intermediate
Description: ANVISA is a very specific and sometimes seen as an "exotic animal" in the regulatory affairs global zoo and, at the same time, Brazil is far from being a negligible market for any medical devices company, most of the times functioning as the basis for Latin America regional access.

This session proposes to give the audience a comprehensive view on how ANVISA is organized, how it operates and thinks, and how to make the best use of information and documents that you may already have in your medical device file or DHF, so that you walk in confidently when engaging with them, taking the biggest possible advantage of your already carefully crafted Technical Documentation or other possible STED-based / ToC-based global regulatory submission packages.

We'll discuss how to pinpoint what are the most important differences and similarities on how this regulator evaluates submissions and go together through the weeds of what usually needs to be adapted and what can be safely kept in its original format, or even benefit of new approaches or of a change of "regulatory storytelling", considering the current processes of regulatory harmonization and convergence.

Learning Objectives:

  • Upon completion, participants will be able to describe how ANVISA functions in both organizational and technical terms, and how to use those characteristics to improve chances of regulatory approvals and avoid common pitfalls in Brazil.
  • Upon completion, participants will be able to spot valuable differences and similarities in the medical device files and/or DHFs and/or regulatory submission packages that they already have, in order to improve speed and effectiveness with a controlled level of risk for Brazil.
  • Upon completion, participants will improve their abilities of previewing costs and timelines for their medical devices submissions in Brazil and also, from a PM standpoint, how to be well-positioned for other major Latam markets.