Brazil IVD Registration and Notification

From notification to full registration, Sobel simplifies every step with strategic expertise, helping your IVD reach the Brazilian market with confidence.

Regulatory Expertise for Brazil IVD Registration

Between technical dossier preparation, document validation, and compliance with Anvisa’s latest standards, the process can be complex and time-consuming. Sobel turns this challenge into a clear, compliant pathway to market.

For who?

For manufacturers and stakeholders needing regulatory support for IVDs in Brazil

By partnering with Sobel, you align your IVD device with current Anvisa expectations—whether you’re working with a Class I device or a complex Class IV solution.

Why do you need this service?

Navigating Brazil’s IVD regulatory framework requires accuracy, local expertise, and constant monitoring of Anvisa updates.

Mistakes in dossier preparation, missing documents, or delays in notification and registration can stall your launch.

Without specialized support, it’s easy to overlook new Anvisa rules or compliance standards, risking market entry.

Your pathway to Brazil IVD registration

Sobel provides complete support for IVD notification and registration in line with Anvisa’s classification rules.

From dossier preparation and document review to labeling, IFUs, and strategic follow-up, we guide your device smoothly through approval until publication in the Official Gazette (DOU).

Your IVD, ready for the Brazilian market.

Which regulatory pathway applies to your IVD

Anvisa classifies IVDs into different pathways depending on their risk and intended use:

Notification
(Class I & II):

Simplified process for low-risk IVDs such as urine strips or pregnancy tests.

Registration (Class III & IV):

Full approval for higher-risk diagnostics like HIV or COVID-19 tests.

Family Grouping:

Similar products with the same use and technology can be registered together.

Change Management:

Any updates to labeling, IFUs, or manufacturing must follow Anvisa’s protocols

From low-risk notifications to complex changes, Sobel helps you navigate every step of your IVD regulatory journey in Brazil.

With Sobel, your product benefits from a responsive, compliant, and experienced local presence—an essential pillar for success in Brazil.

We offer expert representation services tailored for IVD medical devices (Class I to IV), ensuring regulatory compliance and operational efficiency in Brazil.

Avoid registration delays and compliance issues

Communicate directly and professionally with Anvisa

Navigate post-market obligations, including vigilance reporting

Related
Services

Partner with Sobel as your Authorized Representative in Brazil. With Sobel, you minimize risk, ensure regulatory alignment, and position your IVD product for long-term success in Brazil.

We handle the regulatory complexity, so you can focus on innovation.

Brazilian Representative IVD

Authorized legal representation for your IVDs in Brazil with Sobel. Compliance, vigilance and full support.

Regulatory Affairs Support

Navigate regulatory affairs with us, covering planning, gap analysis, and ongoing support.

Risk Management

Get support to meet Anvisa requirements with expert risk management services in Brazil for medical devices.

Your IVD in the Brazilian market

Sobel supports you in every step of the IVD registration journey. From Class I notification to Class IV approval, we help you navigate regulatory complexity with clarity and confidence.

Need expert guidance for IVD registration in Brazil? Contact our team today and take the first step toward successful approval.

Still have questions? Checkout our FAQ

1. What is the difference between IVD notification and registration in Brazil?

IVD registration in Brazil is based on risk class. Certificate of IVD notification applies to Class I and II devices (low risk), following a simplified pathway. Full registration is required for Class III and IV in vitro devices, which involve more documentation and clinical data.

2. How long does it take to obtain an Anvisa IVD approval?

Timelines vary: a certificate of IVD notification may be issued within weeks, while a full in vitro device IVD registration in Brazil can take several months, depending on dossier quality and Anvisa’s review workload.

3. Can a foreign company apply directly for IVD registration in Brazil?

No. Foreign manufacturers cannot submit directly to Anvisa. They must work with a local partner or authorized entity to handle IVD registration and maintain compliance in Brazil. Sobel can act as your legal representative in Brazil, managing IVD registration and ongoing compliance with Anvisa.

4. What documents are required for Anvisa IVD registration?

Each risk classification has its own set of required documents. Sobel provides expert guidance on what is needed for your specific case and supports you in preparing every step of the submission.

5. How does Sobel support the IVD registration process?

Sobel guides national and international manufacturers through every step—risk classification, dossier preparation, submission to Anvisa, and follow-up until approval. Whether you need a certificate of IVD notification or full in vitro device registration, Sobel ensures compliance and accelerates market entry in Brazil.