At the end of August 2026, ANVISA published two guidance manuals dedicated to the regularization of Medical Devices on the Brazilian market, each covering a distinct scope:

The two publications do not introduce new requirements, but consolidate and clarify the operational instructions for properly preparing marketing authorization applications based on their respective regulations.

Notification and Registration: comparing the two pathways

In Brazil, market access is split into two distinct pathways based on device risk class:

  • Notification (notificação): applies to lower-risk devices (Classes I and II), both non-IVD and IVD. It involves no prior technical review before grant, has indefinite validity, and does not require prior submission of the CBPF certificate.
  • Registration (registro): applies to higher-risk devices (Classes III and IV). It requires a comprehensive technical document review by ANVISA, mandatory possession of the CBPF certificate, and has a validity of 10 years, renewable.

Preparing the Submission to ANVISA: Key Points from the Manuals

The manuals translate existing regulations into practical submission instructions. Key aspects to verify prior to submission include:

  • Product Classification and Applicable Pathway: The guides help identify the correct regulatory regime. For non-IVD Medical Devices, classification must follow the 22 rules in Annex I of RDC 751/2022, which determine whether notification or registration applies.
  • Local License Holder and Corporate Authorizations: Applications must be filed by a company established in Brazil holding all applicable authorizations, including the Autorização de Funcionamento de Empresa (AFE) and local sanitary operating licenses. Foreign manufacturers must therefore appoint a Brazilian entity to assume legal and technical responsibility for the products in Brazil.
  • Good Manufacturing Practices: Compliance with Good Manufacturing Practices (Boas Práticas de Fabricação, BPF) remains mandatory. For Class I and II devices, notification does not require the prior submission of a CBPF issued by ANVISA; however, the company must ensure and be able to demonstrate compliance with BPF requirements (RDC 665/2022).
  • INMETRO Certification (Instituto Nacional de Metrologia, Qualidade e Tecnologia): Companies must verify in advance whether the product falls under categories subject to compulsory certification (e.g., certain electromedical equipment). Where applicable, the INMETRO certificate is essential for submission and must remain valid throughout the entire product lifecycle.
  • Procedure selection in Solicita (ANVISA’s Electronic Portal): The manuals emphasize selecting the exact assunto de petição (petition subject code) and its associated document checklist. A simple error in selecting the code or procedure can lead to delays or rejection of the submission.
  • Families, systems, and kits: Grouping models, variants, components, and accessories must meet statutory criteria. For IVDs specifically, family grouping follows strict rules: instruments and reagents constitute distinct categories and cannot be combined within the same family.
  • Technical Documentation: Documentation must include product descriptions, risk management, labelling, instructions for use, and – for IVDs – performance and stability data. The manuals also govern post-market applications (modifications, rectifications, transfers, and cancellations).

Notification does not mean absence of controls

While not requiring prior technical review before approval, notification for Classes I and II is not a mere self-declaration: the technical file must be complete, up to date, and available at the Brazilian company from the time of submission.

ANVISA verifies compliance through document reviews, inspections, and post-market surveillance. Formal clarification requests cannot remedy the initial omission of mandatory elements: missing checklist documents directly triggers summary rejection (indeferimento sumário).

Implications for Manufacturers

The manuals confirm that even for devices subject to notification, entering the Brazilian market demands meticulous preparation: proper classification, a licensed local holder, technical dossier compliance, and advance verification of mandatory certifications and requirements.

>>> Complife supports medical device and IVD manufacturers in defining international regulatory strategies, preparing and reviewing technical documentation, and coordinating applicable testing to ensure pre-market submissions are robust and aligned with target market requirements.

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