What is the role of a Brazilian Registration Holder (BRH)?

A BRH is a legally appointed entity in Brazil responsible for the registration, importation, distribution, and post-market surveillance of medical devices on behalf of foreign manufacturers, as defined by ANVISA.

Does ANVISA accept international quality system certifications?

Yes, ANVISA accepts MDSAP audit reports as part of the B-GMP certification process, facilitating alignment with international quality management system standards like ISO 13485.

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RegulatoryRegulated Pathways Post-Market & Safety Global MarketsANVISA

ANVISA

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

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 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. 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.

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.

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Uses

Concepts or artefacts this term builds on.

Medical Device Single Audit Program(MDSAP)

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Regulatory

IMDRF

International Medical Device Regulators Forum.

Quality & Risk

Medical Device Single Audit Program(MDSAP)

Single audit of a manufacturer's QMS satisfying multiple participating regulators.

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510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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510(k) Summary vs 510(k) Statement

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.

Regulatory

513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

Regulatory

Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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Link health: 3 verified· last checked 2026-06-20

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Category: Regulatory
Acronym: ANVISA
Sources: 3
Updated: 9/19/2026

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Learn in 60 seconds

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

·ANVISA accepts MDSAP audit reports for B-GMP certification and participates in IMDRF.
·CBPF (Brazilian GMP) certification is mandatory for Class III/IV devices.
·Class I and II devices follow the simpler notification route, while Class III and IV need full registration.

Remember this

Watch out: A common mistake is failing to understand the distinction between "Registro" and "Cadastro" and applying for the incorrect submission type, leading to delays.

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