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RDC 830/2023 IVD Framework
IVD Registration & Performance Evidence (Brazil)
IVDs in Brazil are regulated under RDC 830/2023, which updated risk classification, notification/registration procedures, changes, revalidation, cancellation, labeling and instructions for use. The regulatory pathway must connect the intended use, analyte, specimen, target population, risk class and performance claims to the analytical and clinical evidence available.
When This Support Is Needed
Launching a Class I, II, III, or IV IVD in the Brazilian market
An IVD has been reclassified under the modernized RDC 830/2023 framework
A performance claim, validated specimen type, target population, or intended clinical use is changing
Existing EU IVDR or US FDA analytical and clinical performance evidence needs assessment for Brazilian submission
What We Challenge Before Submission
Are the specimen types tested the exact same as those claimed on the Brazilian label?
Do diagnostic sensitivity and specificity claims come from an appropriate population and comparator?
Are cut-off, interference, and cross-reactivity claims adequately supported by objective data?
Does the evidence support every intended-use population, user environment, or clinical setting?
Have reclassification implications under RDC 830/2023 been fully addressed?
Performance Evidence Parameters Reviewed
Analytical sensitivity and limit of detection (LoD) / quantitation (LoQ)
Analytical specificity, cross-reactivity, and potential interferents
Accuracy / trueness and precision (repeatability and reproducibility)
Measuring range, linearity, and high-dose hook effect where applicable
Cut-off determination and clinical decision threshold justification
Specimen stability under transportation, refrigeration, and freeze-thaw cycles
Clinical sensitivity and specificity relative to an established reference method
Comparator / reference method justification and diagnostic concordance
Clinical Substantiation Rule:
We build the IVD submission around the clinical question the test is intended to answer. Every major claim should be traceable to appropriate analytical or clinical performance evidence.
Authorize Your In Vitro Diagnostic with ANVISA
Our diagnostic specialists evaluate analytical performance studies, clinical accuracy, and Portuguese package inserts for RDC 830/2023 compliance.