Brazil ANVISA submissions 50% faster with AI
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Pure Global cuts compilation time in half by leveraging global documentation, automating repetitive steps, and serving as your ANVISA license holder for a simple, turnkey annual fee.
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Pure Global uses agentic AI and your existing approvals to speed up submission compilation work. Our in-house AI compiles ANVISA Notifications in half the time so you can launch in Brazil:
- 50% Faster Compilation: ANVISA submissions are ready in half the time, which saves you weeks across large product portfolios.
- Reuse Global Dossiers: Your FDA 510(k) or CE documentation becomes the foundation for a compliant ANVISA submission.
- Cross-Lingual Translation: We extract data from dossiers in any language to generate localized submissions in Portuguese, validated by local consultants in Brazil.
- Automated Gap Checks: Our system flags missing items instantly with no manual document inventory.
- Expert Oversight: Specialized consultants manage declarations, explanations, and certifications like ANATEL and INMETRO.
- License Holder + Predictable Pricing: From our Brazil office, we file directly with ANVISA for an annual fee that includes compilation, submission, modifications, importation letters, and initial PMS communications. Get an instant estimate with our Fee Calculator.
How our ANVISA submission process works
- Upload your global documentation: Submit your product documentation through our secure portal. A real-time gap analysis flags missing items for registration with ANVISA.
- AI workflow + device-specific assembly: Your ANVISA Notification or Registration form is built and localized automatically while additional requirements are prepped by our specialized team.
- Expert validation: Our ANVISA experts review for accuracy, regulatory consistency, and compliance.
- Submission: As your Brazil license holder, Pure Global submits your dossier to ANVISA for official approval.
Each step is streamlined but fully validated by experts to ensure accuracy, compliance, and a direct path to Brazil’s $9.3 billion medtech import market.
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Our AI workflow plus expert review gets ANVISA submissions ready in half the time. We hold your license and file from our Brazil office, from $2,000/year.
Frequently asked questions
Our annual fee covers ANVISA regulatory requirements throughout the device life cycle: dossier compilation, coordination of ANATEL/INMETRO certifications if required (fees payable to certification bodies not included), submission to ANVISA, modifications and updates, importation letters, and initial PMS communications with authorities. More details on our Pricing page .
One annual fee replaces unpredictable hourly billing. Instead of paying separately for each activity, you pay one annual fee that covers all required services to keep your device compliant in Brazil. This passes the efficiency of our AI-enabled process on to you, with a pricing structure that’s easy to budget. In Brazil, our annual fee starts at $2,000 per Class I/II device and $3,000 per Class III/IV device (excludes government fees). Use our Fee Calculator to estimate your market entry costs and fees in Brazil.
Our process works best for medical devices and IVDs with existing FDA clearance or CE Marking seeking ANVISA Notification (Class I and II devices), though approvals from other major markets are still supported. Devices requiring additional certifications (such as ANATEL for telecom or INMETRO for electrical safety) may require additional steps. Expedited support for ANVISA registration of Class III and IV devices will soon be available.
Portuguese translation is built into the submission compilation. We use our in-house translation platform to integrate regulatory terminology, so you get a localized submission from English to Portuguese without the cost of outsourcing.
Manufacturer declarations, device-specific explanations, and some certifications, still require manual preparation. Our AI workflow eliminates the repetitive inventory and form-filling, while consultants focus on these high-value tasks.
Yes. ANVISA requires a local license holder (sometimes called a Brazil Registration Holder) to represent your product if your company doesn’t have a legal entity in Brazil. From our office in São Paulo, we can fulfill this role and file your notification directly with ANVISA.
Our initial gap assessment flags missing documents and information up front. We’ll identify what’s missing, advise you on how to gather the required information, and integrate it into the submission package.
Yes. Regulators don’t care how a submission is compiled if it is accurate and complete. Our consultants perform a thorough review before any dossier is submitted to ANVISA.
Pure Global can prepare and submit your Notification in less than one week. Once submitted, ANVISA approval is expected within 30 days. Notifications do not need to be renewed.
Single Process,
Multiple Markets
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
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Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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