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    ANVISA

    Brazil's National Health Surveillance Agency, regulating medical devices and IVDs.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ANVISA regulates medical devices under RDC 751/2022 (replacing RDC 185/2001), classifying products into four risk classes and requiring registration (Registro) or notification (Cadastro) plus a Brazilian Registration Holder.

    What this means in practice

    ANVISA accepts MDSAP audit reports for B-GMP certification and participates in IMDRF. CBPF (Brazilian GMP) certification is mandatory for Class III/IV devices.

    Cross-references

    Uses

    Concepts or artefacts this term builds on.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    ANVISA·1IMDRF·1RAPS·1
    1. 1
      ANVISA English
      Needs review
      ANVISAgov.br
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

    Inline markers like [1] jump to the matching reference above.