New Brazilian Medical Device Regulation

What should you know before entering the Brazilian medical device and technology market

A review of the new medical device regulatory landscape in Brazil

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The Brazilian Health Authority, ANVISA, has implemented a new Medical Devices Regulation (the “New Regulation”) as of March 1, 2023.

The New Regulation emphasizes the concepts of product safety and quality, and introduces the following changes:
- Reassessment and requalification of device risks based on technology advances
- non-appealable rejection of faulty filings, including those aimed at securing marketing authorization
- phasing-out and market withdrawal rules for devices
- updating the definition of medical devices by incorporating rules for Software as Medical Device (SaMD) solutions and nanotechnology-based materials
- streamlining labelling and use instructions for devices

To learn more about the new regulatory framework and its application please refer to the following website.

Do you have questions?

Do you need further information about ANVISA and regulatory affairs in general? Contact Bruno Aloi or Letícia de Sena Carita for a free-of-charge consultation with our trusted experts.


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