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 ANVISA

Brazil assigns medical devices to four risk classes:

  • 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 II to RDC 185/2001, which consider intended purpose, invasiveness, duration of body contact, route of administration and consequences of malfunction.

ANVISA allows manufacturers to cross-reference EU MDR classes for guidance. A simplified comparison is:

EU (MDR 2017/745) Brazil (RDC 185/2001)
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.

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 (PMS, 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 185/2001,
  • preparation of Cadastro or Registro dossiers,
  • 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 ANVISA registration help with accessing other LATAM markets?

Yes – some LATAM countries (e.g., Colombia, Ecuador, Paraguay) consider ANVISA approval as preliminary evidence of technical compliance. While each country maintains its own registration process, referencing ANVISA can accelerate documentation review, especially for products already authorized in Brazil.

What are common reasons for delays in ANVISA’s documentation approval process?

Delays often result from language non-compliance in labels and IFUs, lack of local usability data for home-use tests, and insufficient manufacturing process descriptions in technical files. Poor coordination between manufacturers and local importers may also hinder communication with ANVISA and stall application review.

Does ANVISA accept clinical data from studies conducted outside Brazil?

Yes, but such data must meet Brazilian quality standards and be contextualized for the local target population. ANVISA may request additional validation if there are biological, environmental, or language differences that affect the device’s usability or safety. In some cases, supplementary local studies may be required.

What qualifications should an ANVISA-registered importer have?

An importer should not only hold the required licenses (AFE, Alvará), but also have expertise in ANVISA-compliant documentation management, GDP knowledge, and the ability to represent the manufacturer during inspections. The ideal partner is experienced in handling multiple device categories and familiar with Brazil’s public healthcare system (SUS).