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. Class I and II devices follow the simpler notification route, while Class III and IV need full registration. Class III and IV manufacturers generally also need ANVISA Good Manufacturing Practice certification, which can be supported by MDSAP audit reports.

Why it matters

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

Common pitfalls

•A common mistake is failing to understand the distinction between "Registro" and "Cadastro" and applying for the incorrect submission type, leading to delays.
•Manufacturers often underestimate the complexity and time required to establish a compliant Brazilian Registration Holder.
•Neglecting to maintain up-to-date documentation in Portuguese for all regulatory submissions is a frequent oversight.
•Assuming that MDSAP certification automatically guarantees full ANVISA compliance without addressing specific Brazilian requirements can lead to non-conformance.

Sources

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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