September 2, 2026M.A. Gómez

ANVISA publishes two guidance manuals for the regularisation of medical devices

🇧🇷 ANVISA publishes two guidance manuals for the regularisation of medical devices: health-use materials subject to notification (classes I and II) and in vitro diagnostic products

📅 Date: 25 August 2026 🏛️ Source: Agência Nacional de Vigilância Sanitária (ANVISA), Brazil

📝 The essentials

Brazil’s National Health Surveillance Agency (ANVISA) has made available to manufacturers, importers and legal representatives two guidance manuals for the regularisation of medical devices:

  • 📘 Manual sobre Regularização de Materiais de Uso em Saúde Sujeitos ao Regime de Notificação (Gerência de Tecnologia em Materiais de Uso em Saúde – GEMAT, 105 pages, 2026 edition), applicable to health-use materials in risk classes I and II subject to notification under RDC 751/2022.
  • 🧪 Manual para Regularização de Dispositivos para Diagnóstico in Vitro (GEVIT, 84 pages), applicable to IVD products under RDC 830/2023.

🎯 The stated aim of both documents is to “padronizar informações e reduzir inconsistências que costumam gerar exigências técnicas ou indeferimentos” (standardise information and reduce the inconsistencies that tend to trigger technical requests or refusals), as part of the agency’s efforts to improve the quality of incoming applications and help shorten review times.

ℹ️ It is worth stressing that these are guidance documents: they are not a new resolution and they amend neither RDC 751/2022 nor RDC 830/2023.

📋 Contents of the manual on materials subject to notification

The GEMAT manual is structured in four chapters (Informações Gerais; Notificação de Dispositivos Médicos; Petições Secundárias; Considerações Finais) and covers, among others, the following points:

  • 🔍 Risk classification and the applicable regime (notification for classes I and II; registration for classes III and IV) under RDC 751/2022.
  • 🏢 Company prerequisites: the Autorização de Funcionamento (AFE) under RDC 16/2014 (as amended by RDC 860/2024) and the Licença de Funcionamento issued by the local Vigilância Sanitária. On Good Manufacturing Practices (RDC 665/2022), the manual notes that companies with class I and II products are exempt from submitting the Certificado de Boas Práticas de Fabricação (CBPF), without prejudice to the obligation to comply with GMP.
  • 💻 Electronic applications through the Solicita system.
  • 📂 Required documentation and grounds for indeferimento sumário (summary refusal, art. 10, §4 of RDC 751/2022), such as missing or incomplete documents.
  • ⏱️ Timelines: processing of the notification within up to 30 days from filing, and 30 days to respond to requests, with cancellation as the consequence of missing that deadline.
  • 🔄 Secondary petitions: amendment of a notification (immediate implementation), revalidation, transfer of ownership and cancellation (arts. 41 and 42 of RDC 751/2022).
  • ✅ Mandatory INMETRO certification for certain products (for example, needles, syringes, gloves and infusion sets).

⚖️ Regulatory responsibility under the notification regime

The manual reminds readers that, although class I and II products are considered regularised upon notification without a prior technical review, the notification remains subject to documentary audit and inspection by ANVISA at any time, before or after filing. The correct classification of the product, the integrity of the documentation and ongoing compliance therefore remain the responsibility of the notification holder.

📌 At MeDev Consulting we support medical device manufacturers and importers throughout the Brazilian market access process: product classification under RDC 751/2022, preparation of the technical dossier and required documentation, applications to ANVISA through the Solicita system, management of INMETRO certification for products subject to mandatory certification, and follow-up of post-notification obligations. If you wish to regularise your products in Brazil, contact us for an initial assessment of your case.

📩 Shall we talk? https://www.medev.es/en/contacto

🔗 Sources

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