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In Vitro Diagnostics
Health Canada IVD Registration & Performance Evidence
IVDs are classified under a separate Canadian classification framework because risk is driven not only by the assay technology but by how the result will be used and the consequences of an incorrect result.
Our IVD Strategy Includes
IVD qualification and classification under Schedule 1 Part 2
Intended-use and specimen-type review (serum, plasma, whole blood, urine, swab)
Analyte and clinical-use assessment
Near-patient / point-of-care (PoC) considerations
MDL pathway for Class II, III or IV IVDs
MDSAP and QMS alignment
Analytical performance evidence strategy
Clinical performance evidence strategy
Reference method/comparator strategy
Labelling and performance-claim review
Laboratory study coordination
IMDRF ToC dossier development for higher-risk IVDs
Post-market and change-control planning
Analytical Performance Evidence
Precision, repeatability and reproducibility (within-run, between-run, multi-site)
Analytical sensitivity / limit of detection (LoD) & limit of quantitation (LoQ)
Analytical specificity and interference substances
Linearity and measuring range
Cross-reactivity with closely related analytes
Cut-off determination and clinical threshold validation
Specimen stability and transport/storage handling
Reagent stability, open-vial and onboard calibration shelf-life
Clinical sensitivity and specificity relative to reference method
Comparison with reference method or standard comparator assay
Expert Focus:
A performance claim should never be stronger than the study design that supports it. We map intended use and performance claims to the analytical and clinical evidence before the dossier is finalized.
Prepare Your Health Canada IVD Pre-Market Submission
Our diagnostic specialists guide analytical validation studies, comparator assay benchmarking, and bilingual package inserts.