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Exempt devices — Schedule 1

What is a Schedule 1 exemption?​

Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 lists categories of medical devices that do not need to be notified to WAND. These devices are still subject to the Medicines Act 1981 — they must still be safe and fit for purpose, and sponsors retain their obligations — but they are exempt from the WAND notification requirement.

Key exempt categories​

In vitro diagnostic devices (IVDs)​

IVDs are entirely exempt from mandatory WAND notification. Sponsors can choose to notify IVDs voluntarily, and many do. However, it is not required under the current framework.

Custom-made devices​

Devices made specifically for a named individual patient to a written prescription are exempt. This covers custom orthotics, prosthetics, dental appliances, and similar items.

Devices for export only​

Devices manufactured or imported into New Zealand solely for export — not for supply on the NZ market — are exempt. As of 2024, Cabinet has confirmed that the forthcoming Medical Products Bill will also exclude export-only devices from requiring NZ approval.

Devices for clinical investigations​

Devices supplied solely for use in an authorised clinical investigation are exempt from WAND notification during the investigation period.

Devices for evaluation purposes​

Devices provided free of charge and solely for the purpose of evaluation by a healthcare professional (not for patient use) may be exempt.

Voluntarily notifying an exempt device​

Sponsors of exempt devices may still choose to notify WAND. Common reasons include:

  • Providing a formal record for the NZ market
  • Facilitating communication with Medsafe in a safety event
  • Meeting contractual requirements from overseas customers or parent companies

Still subject to the Medicines Act​

Exemption from WAND notification does not mean exemption from other obligations under the Medicines Act 1981:

  • The device must still be safe and effective for its intended use
  • Adverse events involving exempt devices should still be reported to Medsafe
  • Labelling must still comply with GHTF guidance
  • If a recall is needed, Medsafe must still be notified