--- title: "ANVISA, ANVISA | MedTech Terms" description: "Brazil's National Health Surveillance Agency, regulating medical devices and IVDs. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. ANVISA [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)ANVISA # ANVISA Brazil's National Health Surveillance Agency, regulating medical devices and IVDs. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/mdsap) audit reports for B-GMP certification and participates in [IMDRF](/terms/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 What is the primary regulation governing MedTech in Brazil? The primary regulation is ANVISA RDC 751/2022, which outlines the classification, registration, and post-market requirements for medical devices. What is the role of a Brazilian Registration Holder (BRH)? Does ANVISA accept international quality system certifications? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory IMDRF International Medical Device Regulators Forum. ](/terms/imdrf)[ Quality & Risk Medical Device Single Audit Program(MDSAP) Single audit of a manufacturer's QMS satisfying multiple participating regulators. ](/terms/mdsap) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 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. ](/terms/510k-summary-vs-statement)[ 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. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 IMDRF· 1 RAPS· 1 FDA· 1 1. [1 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym ANVISA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=anvisa) Learn in 60 seconds Card Lesson Quiz 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. 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. Related terms - [Medical Device Single Audit Program(MDSAP) ](/terms/mdsap) - [IMDRF ](/terms/imdrf) You may also need Auto-suggested from Regulatory and shared keywords. - [Ministry of Food and Drug Safety (Korea)(MFDS) ](/terms/mfds) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [MHRA / UKCA Marking(MHRA / UKCA) ](/terms/mhra-ukca) - [National Medical Products Administration(NMPA) ](/terms/nmpa) - [Class III Device ](/terms/class-iii) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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