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:
It depends on your regulatory pathway — whether you plan to appoint a Brazilian Registration Holder or register the IVD directly under your company’s name. Each approach has different documentation requirements.
At Sobel, we start every project with a detailed assessment of your regulatory strategy. Based on your goals and product classification, our team prepares a customized list of required documents, ensuring you have full clarity from the very beginning.
Anvisa requires all IVD products to include labeling and Instructions for Use (IFU) in Brazilian Portuguese. These documents must clearly describe the intended use, test procedure, storage conditions, warnings, and any limitations — all in a format that is easy to understand for professional or lay users, depending on the IVD type.
Sobel supports your team in preparing labeling and IFU content that follows Anvisa’s current expectations, helping streamline your submission process.
Anvisa allows certain IVDs to be grouped under a single registration, provided they share key characteristics — such as the same manufacturer, brand, intended use, and methodological principles.
However, grouping rules can be complex and vary depending on the type of IVD (e.g., reagents, analyzers, software). This is why, we evaluate your product portfolio to define the most efficient registration strategy, whether through individual submissions or grouped dossiers.
To register IVDs with Anvisa, foreign manufacturers must appoint a Brazilian Registration Holder (BRH) — a local company legally established in Brazil and authorized to represent the product before the regulatory authority.
Sobel can act as your Brazilian representative, providing full regulatory support throughout the entire lifecycle of your product in Brazil.
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.
Discover the key steps of the IVD product notification and registration process with Anvisa and how Sobel supports you:
Act as your official Anvisa representative, managing registration, compliance, and post-market responsibilities with expertise and agility.
Strategic support to register or notify your IVD in Brazil — with regulatory precision, document preparation, and full process management.
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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