IVD
What is In Vitro Diagnostics? Here’s Everything You Need to Know
What is In Vitro Diagnostics? Discover how IVDs play a vital role in healthcare, the key applications, regulatory pathways, and more.
Bruna MarzarottoAugust 12, 2025
From Class I to IV, registering your in vitro diagnostic medical device with Anvisa requires expertise, local presence, and strategic planning. With Sobel, you simplify the process — without compromising compliance.
Looking for expert guidance to register and maintain their products with Anvisa
Looking for regulatory guidance and local representation
In need of Anvisa-compliant documentation and product notification
Seeking technical support for dossier preparation and Anvisa submissions
To legally market your IVD in Brazil, you must follow Anvisa’s regulatory pathway—based on RDC 830/2023. Devices are classified by risk and processed via notification (Class I/II) or registration (Class III/IV).
But navigating the IVD product notification process with Anvisa can be complex:
At Sobel, we combine technical precision with strategic insight to support your IVD registration in Brazil from start to finish. Our team is deeply familiar with Anvisa’s expectations, including the latest requirements under RDC 830/2023, and we’re prepared to guide you whether your product is Class I or Class IV.
More than just filling out documents, we help define the most efficient regulatory path for your device, adapting our strategy to your product’s risk classification, intended use, and documentation maturity.
We don’t just help you meet the requirements; we help you move faster, avoid rework, and stay focused on innovation while we manage the regulatory complexities.
At Sobel, we combine technical precision with strategic insight to support your IVD registration in Brazil from start to finish. Our team is deeply familiar with Anvisa’s expectations, including the latest requirements under RDC 830/2023, and we’re prepared to guide you whether your product is Class I or Class IV.
More than just filling out documents, we help define the most efficient regulatory path for your device, adapting our strategy to your product’s risk classification, intended use, and documentation maturity.
We don’t just help you meet the requirements; we help you move faster, avoid rework, and stay focused on innovation while we manage the regulatory complexities.
At Sobel, we combine technical precision with strategic insight to support your IVD registration in Brazil from start to finish. Our team is deeply familiar with Anvisa’s expectations, including the latest requirements under RDC 830/2023, and we’re prepared to guide you whether your product is Class I or Class IV.
More than just filling out documents, we help define the most efficient regulatory path for your device, adapting our strategy to your product’s risk classification, intended use, and documentation maturity.
We don’t just help you meet the requirements; we help you move faster, avoid rework, and stay focused on innovation while we manage the regulatory complexities.
At Sobel, we combine technical precision with strategic insight to support your IVD registration in Brazil from start to finish. Our team is deeply familiar with Anvisa’s expectations, including the latest requirements under RDC 830/2023, and we’re prepared to guide you whether your product is Class I or Class IV.
More than just filling out documents, we help define the most efficient regulatory path for your device, adapting our strategy to your product’s risk classification, intended use, and documentation maturity.
We don’t just help you meet the requirements; we help you move faster, avoid rework, and stay focused on innovation while we manage the regulatory complexities.
That’s where a specialized consultancy like Sobel makes the difference. We map your pathway, prepare your dossier, and represent your product before Anvisa.
At Sobel, we combine technical precision with strategic insight to support your IVD registration in Brazil from start to finish. Our team is deeply familiar with Anvisa’s expectations, including the latest requirements under RDC 830/2023, and we’re prepared to guide you whether your product is Class I or Class IV.
More than just filling out documents, we help define the most efficient regulatory path for your device, adapting our strategy to your product’s risk classification, intended use, and documentation maturity.
We don’t just help you meet the requirements; we help you move faster, avoid rework, and stay focused on innovation while we manage the regulatory complexities.
With Sobel, your company gains a trusted partner that understands the local regulatory environment and offers end-to-end support—from classification and dossier preparation to follow-up and post-market changes.
Working together, following our scheduele, you can expect:
Sobel is your regulatory partner for a smooth, strategic, and fully compliant registration process with Anvisa. Talk to our consultant and discover how your IVD product notification process with Anvisa can be managed with confidence and precision.
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