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WAND overview

What is WAND?​

WAND stands for Web Assisted Notification of Devices. It is Medsafe's online database of medical devices that have been notified by their New Zealand Sponsors for supply in New Zealand.

WAND was established under the Medicines (Database of Medical Devices) Regulations 2003 (the WAND Regulations). It is the cornerstone of New Zealand's medical device market entry system.

Why WAND exists​

WAND serves two primary regulatory purposes:

  1. Market visibility — Medsafe needs to know what devices are on the NZ market, who supplies them, and who manufactured them
  2. Safety response — When a safety issue arises (a recall, an international alert, or a reported adverse event), Medsafe uses WAND to identify all affected sponsors and take rapid action

Without WAND, Medsafe would have no reliable mechanism to contact sponsors or trace devices in a safety crisis.

What WAND is not​

important

WAND notification is not pre-market approval. Medsafe does not assess, review, or approve a device when it is notified. Notification confirms only that a Sponsor has registered the device's details. The Sponsor — not Medsafe — is responsible for ensuring the device is safe and performs as intended.

There is no fee for WAND notification. There is no certificate, licence, or approval number issued. Listings do not expire, but they must be maintained by the Sponsor.

Who can access WAND?​

WAND is not a public database. Only the following parties can view WAND entries:

  • The Sponsor who submitted the notification (their own entries only)
  • Medsafe staff

This is in contrast to, for example, the Australian ARTG or the EU EUDAMED database, which are publicly searchable. Patients and healthcare providers in New Zealand cannot look up whether a device has been notified to WAND.

Which devices must be notified?​

All medical devices supplied in New Zealand must be notified to WAND unless they are listed in Schedule 1 of the WAND Regulations as exempt. Key exempt categories include:

  • In vitro diagnostic devices (IVDs) — can be voluntarily notified
  • Custom-made devices
  • Devices for export only
  • Devices used solely for clinical investigations
  • Some low-risk devices in specific use categories

See Exempt Devices for the full Schedule 1 list.

The WAND model in practice​

Manufacturer (overseas)
        ↓
  Appoints NZ Sponsor
        ↓
  Sponsor accesses WAND portal
        ↓
  Sponsor notifies device (within 30 days of becoming Sponsor)
        ↓
  Device on NZ market — supply can begin
        ↓
  Sponsor maintains WAND (updates within 10 days of changes)
        ↓
  Medsafe monitors market via adverse events, signals, WAND data