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In Vitro Diagnostics (Class 1–4)
IVD Regulatory Strategy, Performance Evidence & ARTG Inclusion
Australian IVD regulation is risk-based and classification depends on intended purpose and the potential public-health or personal harm from an incorrect result. IVD market access therefore requires both an ARTG strategy and a performance-evidence strategy that supports the claims made for the assay or system.
When This Support Is Needed
Class 1, 2, 3 or 4 IVD market launch in Australia
Self-testing, point-of-care (PoC), near-patient, or centralized laboratory IVD system
New analyte, specimen type, intended target population, or expanded clinical claim
Transition to new Manufacturer Evidence, IVDR certification, or MDSAP audit basis
Performance study planning, assay validation, or analytical gap remediation
Class 4 high-risk IVD requiring higher scrutiny, preliminary review, and mandatory annual reporting
What We Challenge Before Submission
Performance claims not supported by the exact specimen type or validated population
Clinical performance evidence generated using an inappropriate comparator or reference method
Cut-off values or clinical acceptance criteria not clinically justified
Analytical studies performed on a reagent/instrument configuration different from the marketed assay
IVD intended purpose stated in marketing broader than the study cohort
Class 4 post-market annual reporting responsibilities not operationalised within Sponsor workflows
Our Support Includes
IVD qualification and risk-based classification (Class 1 to 4)
Intended purpose, analyte detection, specimen type, and clinical-use review
Conformity assessment and Manufacturer Evidence pathway strategy
ARTG inclusion and kind-of-device grouping for IVDs
Essential Principles compliance mapping for in vitro diagnostics
Analytical performance evaluation strategy (sensitivity, specificity, LoD, LoQ, precision, cross-reactivity)
Clinical performance evaluation strategy and diagnostic accuracy benchmarking
Performance study design, protocol authoring, and clinical trial coordination
Laboratory coordination with accredited diagnostic testing facilities
IVD labelling, Instructions for Use (IFU), and package insert review
Class 4 annual reporting systems readiness and post-market tracking
Post-market surveillance, vigilance, and IRIS adverse incident reporting
UDI / AusUDID readiness in line with phased Australian implementation
IVD variation, design modification, and lifecycle change control
Senior Regulatory Question:
If the IVD gives an incorrect result, what is the individual and public-health consequence — and does the classification and evidence package reflect that risk?
Authorize Your In Vitro Diagnostic in Australia
Our diagnostic regulatory experts guide analytical studies, clinical performance validations, and ARTG inclusion applications.