ANVISA Registration: bringing your device into compliance for the Brazilian market.

We manage medical device registration, notification and listing with ANVISA, from risk classification to the technical dossier and submission, under RDC 751/2022 (classification and market authorisation) and RDC 665/2022 (Good Manufacturing Practices).

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ANVISA Registration: bringing your device into compliance for the Brazilian market.
What we deliver

We structure the entire product authorisation process, with a traceable technical dossier and a strategy suited to the risk class.

  1. Regulatory assessment and risk classification (Classes I, II, III and IV).

  2. Determining the authorisation pathway (notification or registration).

  3. Preparation of the technical dossier and labelling/IFU to meet ANVISA requirements.

  4. Application, submission and follow-up through to approval.

  5. Management of technical requests, post-registration changes and renewals.

Deliverables

What you receive

A complete technical dossier and compliant labelling/instructions for use.
A submitted application and monitored process number.
Published registration/notification and active market authorisation.
A post-registration maintenance plan (changes and renewals).
References

Reference standards

  • RDC 751/2022 - risk classification and medical device market authorisation.
  • RDC 665/2022 - Good Manufacturing Practices for medical devices.
  • Related ANVISA normative instructions and guidance by product family.
FAQ

Frequently asked questions

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Need to bring your device to the Brazilian market?

We manage registration from initial assessment to approval.

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