All terms
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 the regulation says
ANVISA, Brazil's regulatory body, governs MedTech products through RDC 751/2022, which categorizes devices into four risk classes mirroring international standards. This regulation mandates either a "Registro" (registration) or "Cadastro" (notification) based on the device's risk class, ensuring market control and safety. Furthermore, ANVISA requires a Brazilian Registration Holder (BRH) to act as the legal in-country representative for foreign manufacturers, as stipulated in RDC 751/2022.
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.Examples
- A manufacturer of a Class III orthopedic implant would pursue a "Registro" submission with ANVISA, providing detailed technical documentation and clinical data according to RDC 751/2022.
- A startup developing a Class I general wellness app would likely submit a "Cadastro" notification to ANVISA, a less stringent process than full registration, as per RDC 751/2022.
- A U.S. based MedTech company appoints a Brazilian distributor to act as its Brazilian Registration Holder to manage all ANVISA interactions and regulatory filings.
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.
Frequently asked questions
The primary regulation is ANVISA RDC 751/2022, which outlines the classification, registration, and post-market requirements for medical devices.
Cross-references
Uses
Concepts or artefacts this term builds on.
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Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
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513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
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510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
IMDRF·1RAPS·1FDA·1
- 1
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 2
RAPS Regulatory FocusVerifiedRAPSraps.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.