Skip to main content

WAND submission process

Who submits to WAND?

Only the New Zealand Sponsor can notify devices to WAND. Manufacturers, importers, or distributors cannot submit directly. This reinforces the Sponsor's central legal role — the notification is a statutory act by the entity taking responsibility for the device.


Before you start — what you need

Before beginning a WAND notification, gather the following:

InformationDetail
Device name and modelAs described by the manufacturer
GMDN codeGlobal Medical Device Nomenclature code — see below
Risk classificationThe correct class under Schedule 2 (Class I, IIa, IIb, III, or AIMD)
Manufacturer name and addressRegistered office or principal place of business
Manufacturer contactPhone or email
Sponsor name and addressRegistered office or principal place of business in New Zealand
Sponsor contactPhone or email
ARTG number (optional)If the device is also registered with the Australian TGA

Obtaining a GMDN code

A GMDN code is a mandatory part of WAND notification. The GMDN is an internationally recognised system of generic names and codes for medical devices managed by the GMDN Agency.

To obtain a GMDN code:

  1. Search the GMDN Agency's database for an existing code that matches your device type
  2. If no code exists, you can apply for a new generic term to be created
  3. Many manufacturers already have GMDN codes for their products — check with the manufacturer first

The notification entry

Once in the WAND portal, the Sponsor answers a series of questions about the device. Each question has a drop-down menu. At the end of the process, the Sponsor signs a statutory declaration confirming the information is accurate and that the device meets the requirements of the Medicines Act 1981.

note

Once the notification is submitted and signed, WAND confirms the new notification. There is no waiting period or Medsafe review — the device can be supplied as soon as notification is complete.


The 30-day timeline

WAND notification must be completed within 30 calendar days of a Sponsor taking responsibility for a device. The clock starts from the date the Sponsor agreement is in place — not from the date of first sale.


After notification — keeping WAND current

WAND entries must be updated within 10 working days of any change to:

  • Device details (name, model, specifications)
  • Sponsor details (address, contact information)
  • Manufacturer details (address, contact information)
  • The device's supply status (if it is no longer supplied in NZ)

Failure to keep WAND current is a breach of the WAND Regulations and exposes the Sponsor to enforcement action.


Multiple devices — one entry per device

Each separate device (or device model/variant) requires its own WAND notification entry. A Sponsor managing a large portfolio will have multiple WAND entries. There is no fee per entry.