New Zealand Medsafe Medical Device Notification Service

Scope and evidence must be confirmed before any paid tests or filings.

New Zealand uses Medsafe’s Web Assisted Notification of Devices (WAND) database for the notification of medical devices. The practical task is to determine whether the product is a medical device that must be notified, identify the legally responsible New Zealand sponsor, and enter an accurate sponsor–device record. Notification is free; a consultant’s or sponsor’s commercial fees, if any, are separate.

WAND notification is not Medsafe approval

WAND records device and sponsor information; it is not a Medsafe approval, assessment of safety or performance, or transferable market licence. Regulation 10 prohibits suggesting that listing implies an official endorsement. Regulation 6 specifies notification within 30 working days of becoming sponsor; Medsafe guidance interprets the clock from the device’s first arrival in New Zealand. One older Medsafe WAND overview instead says “30 calendar days”; use the regulation’s working-day wording and confirm timing for unusual arrangements rather than treating the overview as law.

For imported devices, Medsafe’s first-arrival interpretation is relevant; for a local manufacturer, export-only supply or replacement sponsor, do not assume a fresh arrival starts the period. Record when the relevant party became sponsor under regulation 3 and seek written clarification from Medsafe where the trigger is uncertain.

Choose the correct notification route

Situation	WAND decision or boundary
Ordinary non-exempt medical device imported, exported or locally manufactured by a NZ sponsor	Sponsor must notify the device; classification and sponsor identity must be settled first.
In-vitro diagnostic (IVD) fitting the published exemption	Mandatory WAND notification is exempt; voluntary notification is possible. Other device obligations remain.
Custom-made for a particular individual, personal-use import, clinical-trial supply or bonded export	Check the precise Schedule 1 exemption conditions and actual intended use; an exemption is not blanket deregulation.
Product marketed as a cosmetic, medicine or general consumer product	First resolve the New Zealand statutory device definition and therapeutic claims; do not assume foreign categorisation controls.
Reseller buying an already supplied device within NZ	Ordinary domestic resale alone does not require a new importer notification; reassess if exporting, importing, manufacturing or changing intended use.

The sponsor is the relevant person in New Zealand who imports, exports, manufactures or arranges those acts within the definition in regulation 3. WAND access is for NZ-based individuals or organisations; a foreign manufacturer without a local presence cannot simply open its own WAND sponsor account. When two independent NZ importers supply the same device, each must make its own sponsor-specific notification. Australian ARTG inclusion or CE marking does not replace NZ notification.

Important qualification in regulation 3: a person acting only on behalf of another person who is resident or carrying on business in New Zealand at the relevant time is excluded from the definition of sponsor. Therefore the freight agent, customs intermediary and contracting distributor are not automatically the sponsor. Map who actually imports or arranges importation and on whose behalf before choosing the WAND account.

Prepare a WAND-ready evidence packet

Obtain before filing	Why the reviewer needs it
NZ sponsor details and WAND administrator	Local business/contact details; apply for access if the sponsor has no five-digit ID.
Manufacturer’s legal name, site address and contact	Search WAND first; if absent request the manufacturer’s addition before filing.
Device intended purpose, IFU, labelling and model list	Determine whether it is a medical device, the NZ classification and the correct notification boundaries.
GMDN term/code, NZ risk class and product identifiers	Required device data; Class III and AIMD entries need a unique product identifier under regulation 5.
Sterile status, sterilisation method and special device features	Complete device-specific WAND fields; address active devices, systems and medicated/formulated devices as applicable.
Safety/performance documentation and distribution/recall contacts	Keep relevant manufacturer evidence in sponsor files; Medsafe says this evidence is not submitted into WAND.

Submit and retain the WAND record

A practical service should create a traceable file, not merely supply a screenshot of a draft:

Confirm the device scope and any Schedule 1 or IVD exemption; record the reasoning and NZ risk-class basis under Schedule 2.
Identify the sponsor and establish WAND access using Medsafe’s sponsor and administrator process; secure the sponsor’s authority for any adviser assisting.
Check whether the manufacturer already exists in WAND; if not, request addition and allow for Medsafe verification before filing.
Enter the intended purpose, GMDN, classification and device details; review grouping and the regulation 7 declaration before final submission.
Retain the successful notification confirmation, WAND reference and underlying decision record. A saved draft is not a completed notification.

Allow time for access and manufacturer setup: Medsafe says a correctly completed new-sponsor access application is processed within 10 working days, and its quick-reference guide says adding a new manufacturer can take up to 10 working days. These are processing indications, not extensions of the statutory 30-working-day notification period. New Zealand risk classification must be determined under Schedule 2; EU or Australian classes can differ.

When can device models share one notification?

Regulation 5(3), read with 5(5), permits one record for a kind of device only when models are substantially similar, designed for the same use and purpose, made by the same manufacturer, share the same GMDN code and risk classification, and are Class I, IIa or IIb. Fail any test: split the record or clarify with Medsafe. Class III and AIMD cannot use this grouping rule. An accessory or separately supplied component may also need its own assessment; procedure packs need special handling.

Maintain records and manage sponsor changes

Regulation 8 requires corrected information within 10 working days after a recorded detail becomes inaccurate or incomplete, including changes to manufacturer, sponsor or device particulars. Track changes in manufacturer address, certification, device characteristics and the accountable WAND administrator. Medsafe cannot transfer a WAND notification directly to another sponsor: the incoming sponsor creates its own record and the outgoing sponsor makes its old one obsolete. Maintain supply/traceability records and a recall procedure; WAND notification does not discharge post-market duties.

On a sponsor handover, Medsafe's guidance distinguishes the deadlines: the outgoing sponsor normally makes affected records obsolete within 10 working days after ceasing to be sponsor, while the incoming sponsor must notify within 30 working days of becoming sponsor. Do not obsolete records prematurely. For reusable or implantable devices, Medsafe recommends retaining a record while the device still needs support, servicing or maintenance; reconcile that recommendation with an accurate sponsor record and ask Medsafe for case-specific direction if the responsibilities conflict.

Service scope and the next safe action

A properly scoped notification service can deliver a device-by-device route memo, sponsor responsibility check, classification/GMDN data sheet, grouping decision, complete submission record and change-control register. It cannot guarantee Medsafe endorsement or replace the sponsor’s statutory obligations. Start by collecting intended-purpose/IFU documents, model and manufacturer list, NZ supply arrangement, existing WAND sponsor ID (if any), and current regulatory evidence. For broader country-wide obligations, consult the New Zealand market-access overview:

New Zealand product compliance and market access services

Questions about New Zealand WAND notifications

Can an Australian ARTG listing or European CE mark replace WAND?

No. Those documents may help evidence review, but an applicable NZ sponsor–device notification is separate; Medsafe does not approve the device by listing it.

Can two New Zealand importers use the same WAND number?

No. WAND notification is sponsor-specific, even if the manufacturer and model are identical.

Does an exempt IVD escape the Medicines Act entirely?

No. The published IVD exemption concerns compulsory WAND notification, not the safety, labelling or post-market rules otherwise applicable.

Can Class IIb models be grouped if their GMDN codes differ?

No. The grouping rule requires the same GMDN code, manufacturer, classification, intended use and substantial similarity.

What if the sponsor changes or the manufacturer’s address is corrected?

Do not assume transfer of the old WAND record. The incoming sponsor creates its own notification; recorded inaccuracies must be addressed within 10 working days, and the outgoing record made obsolete as appropriate.

Official New Zealand sources

Official legislation and Medsafe guidance: