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    • Market Access
      • Market Access US & International
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      • AI Medical Devices
      • And more…
    • Quality System
      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
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      • Software (IEC 62304, FDA)
      • Risk Management (ISO 14971)
      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
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      • Human Factors Research
      • Safety and EMC test laboratory
      • Biological safety
      • Computer System Validation
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      • Seminar Overview
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October 15, 2024


Approval of medical devices in Brazil

By Margret SeidenfadenOctober 15, 2024Leave a comment

It is not easy to get medical devices approved in Brazil. This is due to the number of regulations, their complexity, and the fact that Brazil has published most of the regulations in Portuguese only. This article provides an overview and highlights similarities with the European and US systems. This will make it easier for you…

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