IVD Registration & Performance Evidence (UAE)

IVD Registration Requires Evidence That Supports the Intended Diagnostic Claim. For IVDs, the regulatory file should connect the intended use, analyte or marker, specimen type, target population, technology, analytical performance, clinical performance, labeling and post-market controls. Existing EU, US or other market evidence can be useful, but it must support the IVD that will actually be marketed in the UAE.

Build Your UAE IVD Strategy

When This Support Is Needed

Commercializing a new in vitro diagnostic (IVD) reagent, kit, or instrument in the UAE market

Transitioning an existing CE-marked (IVDR) or FDA-cleared diagnostic assay to MOHAP registration

Expanding clinical intended uses, specimen matrices, diagnostic cut-offs, or target patient populations

Addressing a MOHAP technical evaluation query regarding analytical sensitivity, specificity, or clinical accuracy

What We Challenge Before Submission

Are all specimen types (e.g. serum, plasma, whole blood, urine) claimed on the UAE label supported by validation studies?

Do diagnostic sensitivity and specificity claims derive from an appropriately sized, representative clinical cohort?

Are analytical cut-offs, cross-reactivity panels, and common interferents fully documented with raw data?

Does the clinical evidence support every intended-use clinical setting (point-of-care, self-test, hospital laboratory)?

Are reagent stability, calibrator traceability, and control values defended under UAE climate storage conditions?

Our IVD Regulatory Support Scope

IVD qualification and Class I, II, III, and IV risk classification under MOHAP rules

Intended clinical purpose, analyte/biomarker, specimen type, and assay format review

Performance-evidence gap assessment against international and MOHAP technical guidance

Analytical sensitivity, Limit of Detection (LoD), and Limit of Quantitation (LoQ) evaluation

Analytical specificity, cross-reactivity, and potential endogenous/exogenous interferent testing review

Accuracy / trueness and precision (repeatability and reproducibility) study evaluation

Measuring range, linearity, and high-dose hook effect documentation

Cut-off determination and clinical decision threshold statistical justification

Specimen stability, transport stability, and in-use / open-vial reagent stability studies

Clinical sensitivity, clinical specificity, and diagnostic concordance evaluation

Comparator method and gold standard reference method justification

Performance study gap assessment and accredited laboratory coordination

Bilingual English and Arabic IVD labeling, packaging artwork, and package insert review

Post-market performance monitoring, vigilance, and diagnostic variation assessment

Performance Rationale:

We ask whether each performance claim is supported by appropriate evidence and whether the tested specimens, comparator, population and acceptance criteria are aligned with the intended UAE use. The goal is a coherent performance argument, not a stack of disconnected reports.

Register In Vitro Diagnostics with UAE MOHAP

Our diagnostic specialists evaluate analytical performance evidence, validate clinical concordance, and compile MOHAP registration dossiers.

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