ANVISA publishes final version (v1.3) of the Medical Device Registration Manual – January 2026

On January 12, 2026, Brazil’s National Health Surveillance Agency (ANVISA) published the final version (v1.3) of the Manual para Registro de Produtos para Saúde – GQUIP. This document consolidates guidance for the registration of medical devices and SaMDs in Brazil.

What’s in the final version?

• The manual applies to medical devices and software as a medical device (SaMD), particularly for registration (registro) procedures.

• It provides step-by-step instructions for structuring and submitting registration dossiers, including:

  • General submission requirements

  • Electronic protocol procedures

  • Applicable fees

  • Technical documentation

  • Transfer of ownership

  • Revalidation of registration

  • Regulatory references and definitions

• The manual reflects the current Brazilian regulatory framework, citing key resolutions (e.g. RDC 751/2022, RDC 837/2023, RDC 848/2024) and related guides on clinical evidence, cybersecurity, and UDI.

Why this matters

The final version replaces prior editions circulated in 2025 and provides manufacturers with clear, structured, and updated regulatory expectations for market access in Brazil.

It also improves alignment with other recent ANVISA regulations—such as those on risk classification, essential safety and performance requirements, and clinical investigations.

The manual is available in Portuguese below.