WAND Exemption & Performance Evidence

IVD Regulatory & Performance Evidence Support (New Zealand)

IVDs Are Exempt From Mandatory WAND Notification — Not From New Zealand Law. In-vitro diagnostic devices are currently exempt from mandatory WAND notification, although voluntary notification is possible. They remain medical devices under the Medicines Act and must still meet applicable safety, sponsor, labelling, advertising, complaint, recall and post-market responsibilities.

Build Your NZ IVD Strategy

When This Support Is Needed

Commercializing an in vitro diagnostic (IVD) reagent, kit, or instrument in the New Zealand market

Assessing whether to utilize voluntary WAND notification or maintain non-notified status for exempt IVDs

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

Ensuring IVD analytical and clinical performance evidence satisfies Medsafe safety expectations

What We Challenge Before Submission

Are all specimen types (e.g. serum, plasma, capillary blood, urine) claimed on the label validated by studies?

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, hospital laboratory)?

Are reagent stability, calibrator traceability, and control values defended under New Zealand transport conditions?

Our IVD Regulatory Support Scope

IVD regulatory status assessment under the Medicines Act 1981

Assessment of voluntary WAND notification strategy and GMDN coding

Intended clinical purpose, analyte/biomarker, specimen type, and target user review

Analytical performance evidence review (sensitivity, specificity, LoD, LoQ)

Clinical performance evidence review (clinical sensitivity, specificity, predictive values)

Precision, repeatability, and reproducibility study evaluation

Interference testing (endogenous/exogenous) and cross-reactivity evaluation

Measuring range, linearity, cut-off determination, and high-dose hook effect documentation

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

Comparator method and reference gold standard justification

Performance study gap assessment and accredited laboratory coordination

IVD labeling, packaging artwork, and Instructions for Use (IFU) review

Post-market performance monitoring, vigilance, and recall readiness

Performance Rationale:

We do not force an EU IVDR or Australian IVD class onto the current New Zealand WAND framework. We focus on the legal status in New Zealand and whether the available analytical and clinical evidence actually supports the intended purpose and claims of the IVD being supplied.

Substantiate In Vitro Diagnostics in New Zealand

Our diagnostic specialists evaluate analytical performance evidence, validate clinical concordance, and manage voluntary WAND listings.

Book a Consultation