Brazil Anvisa 2025 Guidance on Medical Device Certificate Issuance

Brazil’s Anvisa has launched the 2025 medical device certificate tool, replacing the older Sicert system to streamline regulatory compliance. Integrated with Solicita, the new platform offers updated templates, clearer layouts, translations, and certificate previews, enabling faster and more transparent issuance for manufacturers, importers, and distributors. Understanding how to transition from Sicert to the new tool is critical for companies seeking uninterrupted medical device certification in Brazil.

Key Updates in Anvisa Medical Device Certificate Tool 2025

• Integration with Solicita: Centralizes all certificate requests into one modern system.

• New Certificate Templates: Redesigned layouts, English/Spanish translations, optional inclusion of manufacturing units, full device model listings, and detailed IVD components.

• Preview Before Submission: Companies can verify details before generating the payment slip.

• Operational Date: Tool went live on November 19, 2025, ahead of the Sicert shutdown.

Sicert Phase-Out and Transition

• Sicert will only validate existing certificates during the transition period.

• No new certificates can be issued after December 1, 2025.

• Anvisa advises companies to wait for the new tool activation before submitting requests to ensure documents are valid post-Sicert shutdown.

Certificate Validation Process

• External Consultation: Enter issue date, code, and digital hash from the footer.

• QR Code Scan: Automatically opens the validation page with pre-filled details.

• Detailed step-by-step instructions are available in Chapter 7 of the Solicita User Manual.

Why This Change Matters

• Efficiency: Solves technological and usability limitations of Sicert.

• International Alignment: Translations and updated templates support global compliance.

• Enhanced Security: Digital signatures, QR codes, and hash codes increase traceability.

• Reduced Regulatory Risk: Early adoption ensures uninterrupted certification beyond December 1, 2025.

Recommended Actions for Companies

1. Migrate to the New Tool Now – Avoid last-minute compliance issues.

2. Train Regulatory Teams – Ensure staff understand the new platform and certificate templates.

3. Review Device and Component Data – Check all models match Anvisa records, including IVD devices.

4. Organize Existing Sicert Certificates – Keep for validation purposes.

5. Inform Partners and Exporters – Communicate the updated format, translation options, and QR code verification.

Internal Links:

• Learn more about Anvisa medical device registration

• Learn about our newly launched AI builder currently operational for Brazil ANVISA notifications and registrations

External Links:

• Official Anvisa press release  

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