Back to Saudi Arabia Overview
Class A-D In Vitro Diagnostics
IVD Registration & Performance Evidence (SFDA)
IVDs Require a Dedicated Performance-Evidence Strategy. SFDA classifies IVD medical devices as Class A, B, C or D based on individual and public-health risk. The regulatory strategy should connect the intended purpose, analyte or marker, specimen type, target population, classification, analytical performance, clinical performance and post-market obligations.
When This Support Is Needed
Commercializing a new Class A, B, C, or D in vitro diagnostic (IVD) medical device in Saudi Arabia
Transitioning an existing CE-marked (IVDR) or FDA-cleared diagnostic test to the SFDA GHAD portal
Expanding clinical intended uses, specimen types, diagnostic cut-offs, or target patient populations
Addressing an SFDA technical deficiency regarding analytical sensitivity, specificity, or clinical accuracy
What We Challenge Before Submission
Are the specimen types (e.g. serum, plasma, capillary blood, saliva) validated in performance studies identical to label claims?
Do diagnostic sensitivity and specificity claims derive from a statistically powered, 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, central lab)?
Are reagent stability, calibrator traceability, and control values defended under Saudi climate storage conditions?
Our IVD Regulatory Support Scope
IVD qualification and Class A, B, C, and D risk classification under SFDA rules
Intended clinical purpose, analyte/biomarker, specimen type, and assay format review
Performance-evidence gap assessment against SFDA technical guidance
Analytical sensitivity and Limit of Detection (LoD) / Limit of Quantitation (LoQ) evaluation
Analytical specificity, cross-reactivity, and endogenous/exogenous interference evaluation
Accuracy / trueness and precision (repeatability and intermediate precision) testing review
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
Clinical performance study protocol authoring and laboratory coordination
Bilingual Arabic and English IVD labeling, packaging artwork, and package insert review
Post-market performance monitoring, vigilance, and diagnostic variation assessment
Performance Focus:
Our focus is not whether a performance report exists. We evaluate whether the analytical and clinical evidence actually supports the intended purpose and claims for the IVD that will be marketed in Saudi Arabia.
Obtain SFDA Marketing Authorization for In Vitro Diagnostics
Our diagnostic specialists evaluate analytical performance evidence, validate clinical concordance, and compile MDMA submissions in GHAD.