WAND Notification & Sponsor Readiness (Medsafe)

WAND Notification Is a Legal Notification — Not a Product Approval. For most medical devices, the New Zealand Sponsor must notify prescribed information to the Web Assisted Notification of Devices (WAND) database within 30 calendar days of becoming the sponsor. The sponsor is also responsible for ensuring that notified information remains accurate and is corrected when it changes.

Prepare Your WAND Notification

When This Support Is Needed

A New Zealand Sponsor must notify a medical device or SaMD to the Medsafe WAND database within 30 calendar days

Transitioning an existing product line or adding new models, sizes, or catalogue codes to WAND

Correcting or updating manufacturer, sponsor, intended purpose, or classification data in WAND

Establishing multi-importer WAND notification records for the same foreign-manufactured device

What We Challenge Before Submission

Has the notification been submitted within 30 calendar days of the device first arriving in New Zealand?

Does the declared GMDN descriptor accurately match the intended clinical use of the product?

Are manufacturer legal name and address details identical to overseas regulatory certificates?

For Class IIb, III, and AIMD devices, are all required product identifiers accurately entered in WAND?

Is there a documented process to notify Medsafe promptly whenever notified WAND information changes?

Our WAND Notification Support Scope

WAND sponsor account setup, delegation, and administrator readiness

Manufacturer corporate detail and manufacturing site verification

Device notification strategy and model family grouping assessment

Risk-class (Schedule 2) and GMDN preferred term review

Product identifier (make, model, catalogue/part number) review for higher-risk devices

WAND electronic form compilation, data-entry, and submission support

Post-notification verification and confirmation record archiving

WAND database correction and update support when device details change

Sponsor detail, corporate address, or authorized administrator change filings

Statutory 30-day timeline compliance management for imported consignments

Quality Check Rule:

We quality-check the regulatory basis behind each WAND field. The objective is not just to complete the database entry, but to ensure the sponsor can stand behind the classification, GMDN, manufacturer details, intended purpose and device information declared in WAND.

Notify Your Medical Devices to Medsafe's WAND Database

Our New Zealand regulatory specialists manage WAND database submissions, verify GMDN descriptors, and ensure statutory compliance.

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