Brazil’s National Health Surveillance Agency (ANVISA) has recently announced an important change in the risk classification of the ultrasensitive CRP (C-reactive protein) parameter, which has been downgraded from class III to class II. This regulatory change represents a significant advancement for manufacturers and importers of in vitro diagnostic (IVD) medical devices in Brazil.
What Has Changed?
According to Technical Note 17/2025/SEI/GEVIT/GGTPS/DIRE3/ANVISA, the reclassification of the ultrasensitive CRP parameter results in a simplification of the regulatory process, as class II devices are subject to a notification regime, which is less complex than the registration required for class III devices.
This measure aligns with Collegiate Board Resolution (RDC) 830/2023, which regulates the notification and registration of in vitro diagnostic medical devices in Brazil. RDC 830/2023, which came into effect in June 2024, brought a series of updates to risk classification rules, seeking harmonization with international standards and an approach based on the actual risk of products.
Impact for the Sector
The reclassification of ultrasensitive CRP to class II represents an important advancement for the in vitro diagnostic sector in Brazil, mainly due to:
- Simplified regulatory process: The notification regime is less complex and costly than registration.
- Cost reduction: Fewer documentary requirements and lower regulatory fees.
- Faster market access: Reduced regulatory approval time.
- Alignment with international standards: More consistent classification with global regulatory practices.
What is Ultrasensitive CRP?
Ultrasensitive CRP is a laboratory test that measures extremely low levels of C-reactive protein in the blood, a protein produced by the liver in response to inflammatory processes. Unlike conventional CRP, the ultrasensitive test can detect much lower concentrations, making it particularly useful for assessing cardiovascular risk and monitoring low-grade inflammation.
This test is widely used in clinical practice for:
- Cardiovascular risk assessment
- Monitoring of chronic inflammatory diseases
- Follow-up of anti-inflammatory treatments
- Early diagnosis of inflammatory processes
Deadlines and Guidance for Compliance
Companies that have already filed applications for sanitary reclassification will be contacted directly by the Management of In Vitro Diagnostic Products (GEVIT) for guidance on alternative courses of action. The same procedure will be adopted for registrations (class III) filed or granted during the validity of RDC 830/2023.
It is important to note that the deadline for sanitary reclassification set forth in RDC 830/2023 has not yet ended, extending until June 2, 2025. This provides companies with sufficient time to adapt to the new rules.
Regulatory Context
The reclassification of ultrasensitive CRP is part of a broader movement to modernize the Brazilian regulatory framework for medical devices. RDC 830/2023, which replaced the former RDC 36/2015, seeks to harmonize Brazilian regulation with international best practices, such as the European Regulation for In Vitro Diagnostic Medical Devices (IVDR, 2017/746) and the guidelines of the International Medical Device Regulators Forum (IMDRF).
This regulatory evolution reflects ANVISA’s commitment to establishing a more efficient and risk-proportional regulatory environment, favoring innovation and access to diagnostic
technologies without compromising the safety and efficacy of products available in the Brazilian market.
Conclusion
The reclassification of the ultrasensitive CRP parameter to class II represents a positive measure that simplifies the regulatory process for manufacturers and importers, potentially expanding access to this important diagnostic tool in Brazil. Companies in the sector should be attentive to ANVISA’s deadlines and guidelines to ensure a smooth transition to the new sanitary framework.
For companies that need regulatory support in this transition process, having specialized consulting can be essential to successfully navigate this evolving regulatory landscape.
Our team specialized in regulatory affairs is available to support your company in this transition.
This article was prepared based on official information provided by ANVISA. For more details, we recommend consulting Technical Note 17/2025/SEI/GEVIT/GGTPS/DIRE3/ANVISA and RDC 830/2023 directly.
Link to original news: Guidance on sanitary framework for ultrasensitive CRP parameter — Brazilian Health Regulatory Agency – ANVISA
ANVISA official website: www.gov.br/anvisa
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