How do I know if my device classification changed under new Brazil device regulations?

ANVISA will not contact you if your device or IVD classification has changed. You must perform a classification assessment to confirm your classification under RDC 751 or RDC 830. The new classification rules are almost identical to the classification rules in the EU Medical Devices Regulation (EU MDR 2017/745) and EU In Vitro Diagnostic Devices Regulation (EU IVDR 2017/746). If you already have CE Marking under the MDR or IVDR, your classification is likely to be the same under Brazil’s new regulations.

How does medical device family grouping affect my registration requirements and costs in Brazil?

Grouping allows you to compile a single notification or registration application for multiple products with the same characteristics (e.g., its intended use, indications for use, legal manufacturer, etc.). However, grouping criteria vary by device type. Accessories can sometimes require their own approval, as well. Separate registrations will incur additional fees and, depending on the classification of a separate device or accessory registration, additional regulatory requirements.

Do I need a Brazil Registration Holder for Notification of a Class I or II device?

Yes. You must designate a BRH if you don’t have a legal entity in Brazil, even for the notification process. Your BRH will keep a copy of your technical file, labeling, and Instructions for Use (IFU) on file, as well as liaise with ANVISA as needed for post-market compliance, such as event reporting, recalls, etc.

How does Brazil device classification affect QMS requirements?

Class I and II devices are exempt from Brazil Good Manufacturing Practice (BGMP), ANVISA’s quality management system requirements. Manufacturers of class III and IV devices must obtain BGMP certification by passing an audit by ANVISA. In general, the certificate is submitted with your registration application, though it’s possible to apply for ANVISA registration before your BGMP audit is complete. If your ANVISA registration is approved, it is conditional on your BGMP audit.

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Brazil

Brazil ANVISA submissions 50% faster with AI

Brazil ANVISA submissions 50% faster with AI

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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AI-supported ANVISA submissions

Smarter Market Access, Powered by Automation

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 notifications are ready to submit in half the time. Save 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 consultants.
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 São Paulo office, we file directly with ANVISA for an annual fee that includes compilation, submission, modifications, importation letters, and initial PMS communications.

How it works

Upload your global documentation: Submit your product documentation through our secure portal. Real-time gap and readiness check flags missing items or registration with ANVISA.
AI workflow + device-specific assembly: Notification form is built and localized automatically while additional requirements are prepped by our specialized team.
Expert validation: ANVISA consultants review for accuracy, regulatory consistency, and compliance.
Submission: As your license holder, Pure Global submits the 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.

more information on Brazil

Post-Market Surveillance and Vigilance

ANVISA Registration

Medical Device Regulations

Labeling Requirements

Documents and Links

Resolution (RDC) 751/2022

Resolution (RDC) 830/2023

How We Can Help

Faster submissions. Predictable costs. Local support.

Brazil’s booming device market is within your reach. With Pure Global, your existing approvals are your shortcut: we cut compilation time in half, streamline every requirement, and act as your local representative so you can start selling in Brazil.

Frequently
Asked Questions

What’s included in the annual fee?

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.

How does the annual fee work?

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.

What types of products are eligible for this streamlined process?

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.

Do I still need to translate my documents for ANVISA?

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 without the cost of outsourcing.

What parts of the submission are still manual?

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.

Do I need an ANVISA License Holder?

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.

What if my FDA or CE dossier has gaps compared to ANVISA’s requirements?

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.

Will ANVISA accept a dossier built with AI?

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.

How long does ANVISA approval take for Notification submissions?

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.