ANVISA – Brazil’s main medical-device regulator
ANVISA (Agência Nacional de Vigilância Sanitária) is the authority responsible for oversight and market approval of medical devices in Brazil. Its remit covers licensing manufacturers and importers, registering devices, and inspecting quality-management systems both domestically and at foreign production sites.
Across LATAM, ANVISA’s regulations are viewed as a benchmark. Other countries in the region – such as Argentina, Mexico and Colombia – often reference the Brazilian framework when developing their own rules. For manufacturers this means that securing approval in Brazil can ease entry to neighbouring markets.
Device-risk classification under RDC 751/2022
Brazil assigns medical devices to four risk classes:
| Class | Risk level |
|---|---|
| Class I | low risk |
| Class II | low-to-moderate risk |
| Class III | moderate-to-high risk |
| Class IV | high risk |
Classification follows the criteria in Annex I to RDC 751/2022 (in force since 1 March 2023), which replaced the earlier RDC 185/2001. The new regulation introduced 22 classification rules, largely mirrored on the EU MDR’s own device classification rules – covering intended purpose, invasiveness, duration of body contact, route of administration and consequences of malfunction. The overhaul also added categories the old law never anticipated, such as software as a medical device (SaMD).
ANVISA allows manufacturers to cross-reference EU MDR classes for guidance. A simplified comparison is:
| EU (MDR 2017/745) | Brazil (RDC 751/2022) |
|---|---|
| Class I | Class I |
| Class IIa | Class II |
| Class IIb | Class III |
| Class III | Class IV |
Registration routes – Cadastro and Registro
ANVISA operates two main pathways, depending on class.
1. Cadastro (notification)
Applies to Class I & II devices. The manufacturer (through a Brazilian importer) submits a streamlined dossier covering company data, declaration of conformity, technical description, IFU, labels and translations. ANVISA issues a notification number that authorises market placement.
2. Registro (full registration)
Required for Class III & IV devices. A comprehensive technical file is submitted, including clinical data where applicable, quality certificates, test results and detailed manufacturing information. ANVISA reviews the dossier and may audit the manufacturing site.
The importer must hold a Brazilian establishment licence – Autorização de Funcionamento (AFE) – as well as state or municipal permits, on top of the broader importer obligations that apply across Brazil’s regulatory framework.
The foreign-authorisation reliance route (AREE)
Since Normative Instruction IN 290/2024 took effect, manufacturers of Class III and IV devices can use a simplified pathway based on Autoridades Regulatórias Equivalentes (AREE) – recognised foreign regulatory authorities. Australia, Canada, the US and Japan currently hold AREE status. If a device already holds approval in one of these countries — for the exact same intended use submitted to ANVISA – the manufacturer can leverage that existing regulatory dossier instead of building one from scratch, while still completing a technical file compliant with RDC 751/2022.
For companies already pursuing US registration or Canadian registration, this creates a real opportunity to accelerate entry into the Brazilian market – provided the submitted intended use is identical across markets.
Specifics for IVD registration
IVDs follow the same class rules, but documentation requirements vary with test type, intended use and diagnostic risk. High-risk assays (e.g. HIV, HCV, COVID-19) demand additional clinical-performance data and ANVISA – compliant validation.
Self-testing kits or home-use assays require local usability studies and consumer-facing materials in Brazilian Portuguese. Inaccurate labelling or IFU translations can delay approval for months.
Manufacturer registration and importer obligations
A foreign manufacturer cannot file directly with ANVISA – it must act via a local importer. The importer needs a CNPJ number, an AFE licence and an active operating permit (Alvará). It must maintain GDP-compliant records and make products available for inspection.
Manufacturer and importer sign a contract covering documentation updates, change control and post-market safety activities, including post-market surveillance and incident reporting (vigilance).
How Pure Clinical supports MD and IVD registration in Brazil and LATAM
ANVISA’s system is complex, and procedural differences between classes can lead to costly errors. Pure Clinical guides international companies through every step – tailored to Brazil’s requirements and the broader LATAM context.
Our support includes:
- risk-class analysis under RDC 751/2022,
- preparation of Cadastro or Registro dossiers,
- assessing eligibility for the simplified AREE pathway (Class III–IV devices already approved in the US, Canada, Australia or Japan),
- review of IFU, labels and translations for ANVISA compliance,
- co-ordinating with local importers and drafting legal agreements,
- tracking application status and liaising with ANVISA,
- pre-registration audits and readiness checks.
With regional expertise and on-the-ground partners, we ensure a smooth path to approval – even for high-risk or innovative IVDs.
FAQ
Can an ANVISA registration support market access in other LATAM countries?
What typically causes delays in ANVISA’s document review process?
Does ANVISA accept clinical data generated outside Brazil?