What Procedures Are Required to Export Medical Devices to Brazil?

Direct answer: To export medical devices to Brazil, manufacturers must first confirm the device risk classification (Class I–IV) under ANVISA RDC 751/2022 and appoint a Brazilian Registration Holder (BRH). The manufacturer then prepares the technical file, conformity declaration, B-GMP/ISO 13485 evidence, Portuguese labelling and instructions for use, clinical evaluation (Class III/IV) and applicable test reports, and files either a Cadastro (notification) or Registro (registration) with ANVISA. Registrations remain valid for an indefinite period, subject to continued compliance with post-market conditions. ANVISA has not published an official review timeline.

Key Requirements

• Competent authority: Brazilian Health Regulatory Agency (ANVISA — Agência Nacional de Vigilância Sanitária), https://www.gov.br/anvisa/
• Applicable products: Medical devices, classified by risk as Class I–IV in accordance with RDC 751/2022.
• Core documentation: (1) appointment of a Brazilian Registration Holder (BRH); (2) technical file (dossiê técnico); (3) conformity declaration; (4) quality management system evidence (B-GMP/ISO 13485); (5) product labels and instructions for use in Portuguese; (6) clinical evaluation documentation (Class III/IV); (7) sterilization, biocompatibility and other test reports as applicable to the device; (8) import and local manufacturing licences, where applicable to the legal entity.
• Certificate validity: Indefinite. RDC 751/2022 abolished periodic revalidation; continued compliance with post-market obligations is required.
• Local representative: Required. A Brazilian Registration Holder (BRH) must be appointed.

Professional Notes

RDC 751/2022 — Risk Classification, Notification and Market Authorization Regime: https://www.gov.br/anvisa/en/rules-and-regulations/arquivos/rdc-751_2022.pdf

Verification date: 2026-10-30.

Frequently Asked Questions

What is the difference between the procedures for Class I/II and Class III/IV devices?

Class I/II devices follow the Cadastro (notification) pathway, for which the documentation requirements are comparatively simplified. Class III/IV devices follow the Registro (registration) pathway, which requires clinical evaluation data and undergoes a more stringent review.

Is a Brazilian Registration Holder mandatory?

Yes. A foreign manufacturer must appoint a BRH to act as the registration holder and assume local post-market responsibilities.

Does the registration certificate expire?

Since RDC 751/2022, periodic revalidation has been abolished and registrations remain valid for an indefinite period, provided that post-market conditions continue to be met.

In what language must labels and instructions for use be provided?

Portuguese. The specific requirements are subject to ANVISA guidance.

Scope of Support

• Manage products, regulations, documentation, tasks, submissions and certificates through a digital workspace, and map the procedures required for Brazilian Cadastro or Registro in accordance with RDC 751/2022.
• Generate documentation gap lists and track ANVISA submission and post-market obligation milestones.

Limitations

• We do not act as a CRO or agent in liaising with ANVISA on behalf of manufacturers, nor do we sign BRH appointment documents.
• We do not handle B-GMP certification, and we do not provide or substitute for a Brazilian Registration Holder entity.

Verification date: 2026-10-30. Prepared by Ameli, a digital platform for overseas medical device registration management covering products, regulations, documentation, tasks, submissions and certificates. Ameli is not a CRO and does not act as an agent. Facts on this page are based on official sources; figures that have not been published are marked as "not officially disclosed".