Submission File Elaboration
To enter the Brazilian market, your medical device must comply with Anvisa’s requirements. Having all the necessary documentation well organized is the first step toward a successful regulatory journey.
Our team assists organizations in structuring and gathering all necessary technical information to register their medical device with Anvisa, in compliance with national legislation and regulatory standards.
Whether you are launching a new product or expanding your international footprint, we streamline the submission process and simplify the complexities associated with medical device regulation in Brazil.
How we support your medical device
Registering a medical device in Brazil may seem complex at first glance, but with the right guidance, the process becomes much smoother. That’s where our team comes in: we offer a comprehensive regulatory support service, handling every step of the submission to Anvisa — from product classification to the development of the technical dossier.
It’s important to understand that Anvisa classifies medical devices into four risk classes: I, II, III, and IV. This classification determines the regulatory pathway to be followed. Our role is to identify exactly where your device fits in order to prepare a technical dossier that leads to a swift and surprise-free approval.
We are your strategic partners. That’s why our support is tailored to the specific needs of your device, whether it falls under Class I or Class IV. We help your business by:
Reviewing product classification to define the correct regulatory pathway;
Compiling and organizing all technical documentation required by Anvisa;
Developing the technical dossier in accordance with RDC 751/2022, which also defines the accepted languages;
Providing guidance on the format, language, and translation requirements for documents;
Cross-referencing existing certifications and post-market data to strengthen your submission;
Assist with questions related to additional certifications, such as BGMP (mandatory for Classes III and IV), INMETRO (for electrical equipment), and ANATEL (for wireless communication devices).
Why do you need this service?
Efficient documentation strategy: A clear plan and well-prepared submission file help prevent unnecessary corrections and resubmissions.
Accurate and complete technical file: A properly structured technical dossier increases the chances of regulatory acceptance.
Possibility of a faster registration process: With expert support and document validation, your submission moves through the system more smoothly.
We help bridge the gap between global documentation formats and Brazilian regulatory requirements—simplifying the process so your team can stay focused on business priorities.
Need Assistance with Submission File Preparation?
Whether you’re compiling a technical dossier Anvisa for a new product or updating documents for an existing medical device Anvisa, our team is ready to help.
Our experience with medical device regulation in Brazil allows us to assist international manufacturers through every stage of the process.
From initial planning to submission, we act as a strategic partner focused on regulatory precision and operational efficiency.
Take the next step toward hassle-free market entry in Brazil!
