Medsafe and WAND: are CPAP machines approved?

1 min read By HHZ Editorial Next review

New Zealand has no approval system for medical devices under the Medicines Act 1981. Instead, every importer or local manufacturer must notify each device to Medsafe’s WAND database within 30 calendar days of becoming its sponsor. Notification is free and is required for legal supply, but Medsafe says it does not mean the device has been assessed for quality, safety or efficacy.

This guide is written from Medsafe’s pages on the WAND database, what WAND is and importing medical devices, read on 14 October 2026. It isn’t legal advice.

No pre-market approval

Medsafe says:

  • There is no approval system for medical devices under the Medicines Act 1981.
  • There is no mandatory requirement for devices to be approved by any regulator before being supplied in New Zealand.
  • Notification to WAND does not mean Medsafe has assessed the device for quality, safety or efficacy.

This differs from Australia, where devices must be included on the ARTG, and Canada, where Class II and higher devices need a Health Canada licence before sale.

What WAND is

The Web Assisted Notification of Devices (WAND) database was set up by the Medicines (Database of Medical Devices) Regulations 2003.

  • Devices must be notified to WAND to be legally supplied in New Zealand.
  • Notification is free, with no ongoing fees.
  • It must happen within 30 calendar days of a person or organisation becoming the device’s sponsor.
  • Importers, exporters and local manufacturers must all notify their devices.

Every importer notifies separately

A WAND notification covers one sponsor and one device. If several companies import the same CPAP machine, each one must notify it; one importer can’t rely on another’s notification. Sponsors must keep supply records so they can trace customers in a recall.

What this means for you

  1. Buy from a New Zealand supplier that can tell you it has notified the device.
  2. Medsafe uses WAND to contact sponsors when there is a safety problem, so a machine bought overseas may not be traced in a recall.
  3. Check Medsafe’s online recalls database for your model.

For devices sold here, see CPAP machine prices and oxygen concentrator prices.

Frequently asked questions

Does Medsafe approve CPAP machines?
No. Medsafe says there is no approval system for medical devices under the Medicines Act 1981 and no requirement for devices to be approved by any regulator before supply in New Zealand.
What is WAND?
The Web Assisted Notification of Devices database, set up by the Medicines (Database of Medical Devices) Regulations 2003. Devices must be notified to it to be legally supplied.
Does a WAND listing mean a device is safe?
No. Medsafe says notification does not mean or imply the device has been assessed for quality, safety or efficacy.