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Special device types

Software as a Medical Device (SaMD)​

New Zealand currently applies GHTF and IMDRF guidance to determine whether software is a medical device. Rule 11 of Schedule 2 is the primary classification rule for standalone diagnostic/therapeutic software:

  • Software that provides diagnostic or treatment decision support is generally Class IIa as a minimum
  • Software that could cause death or irreversible deterioration if it fails is Class IIb or III
  • General-purpose clinical software (e.g., electronic health records) is generally not a medical device

See SaMD and Digital Health for full guidance.

Borderline products — device vs medicine​

When a product has both a device component and a medicinal component, the regulatory pathway depends on the principal mode of action:

  • If the primary effect is achieved by the device mechanism → regulated as a medical device
  • If the primary effect is achieved pharmacologically → regulated as a medicine

For combination products where the medicinal substance is integral (e.g., antibiotic-coated bone implants), the device is classified as Class III under Rule 13.

Use Medsafe's categorisation service for borderline cases.

Accessories​

Accessories to medical devices — items specifically intended by their manufacturer to be used with a device to enable it to function as intended — are themselves medical devices. Accessories are classified independently using the same 22 rules, not automatically assigned the class of the parent device.

Systems and procedure packs​

A system is a combination of products that are packaged together and intended to be used together to achieve a specific medical purpose. A procedure pack is a combination of products assembled to address a specific clinical procedure.

The Sponsor of the system or pack is responsible for ensuring all constituent components are appropriately classified and notified to WAND.

Custom-made devices​

A custom-made device is a device made specifically for a named individual patient to a written prescription from a qualified healthcare professional.

Custom-made devices:

  • Are not required to follow standard conformity assessment routes
  • Are generally exempt from WAND notification (see Schedule 1 exemptions)
  • Must still be safe and fit for purpose
  • Must carry an appropriate statement in labelling indicating they are custom-made

Reprocessed single-use devices​

The reprocessing (cleaning, sterilisation, and reuse) of single-use devices (SUDs) is an area Medsafe has not separately regulated to the same extent as the EU or US. However:

  • The reprocessor becomes the manufacturer for regulatory purposes
  • The reprocessor must classify the device and, if WAND notification is required, act as Sponsor
  • Liability for post-reprocessing performance rests with the reprocessor

Devices incorporating human tissue​

Devices that incorporate non-viable human tissue or cells as an integral part are classified as Class III (or higher) and require robust technical documentation. The Human Tissue Act 2008 may also apply to the tissue component itself.