Multiple Importers and Independent WAND Notifications in New Zealand

1. Key takeaways

Regulatory information verified as of 29 October 2026. When a device has N importers in New Zealand, it generates N independent WAND (Web Assisted Notification of Devices) notifications. They are not shared, not merged, and not discharged because someone else has notified. Medsafe’s page Importing Medical Devices into New Zealand (4Importing.asp, revised 21 September 2015) states it plainly: A WAND notification is specific to a particular combination of sponsor (importer) and device.

The legal basis is reg 3 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325): a sponsor is a person who imports the device into New Zealand or arranges its import. The definition is assessed entity by entity and device by device. Two New Zealand companies importing the same model from the same manufacturer each become a sponsor, each bearing the 30 working-day notification duty in reg 6, the reg 7 declaration, the 10 working-day correction duty in reg 8 and the procedure duty in reg 9.

On cost, one point is easily confused: WAND notification is free, with no ongoing fees, as Medsafe states officially. The price of duplicate notifications lies not in fees but in governance: every sponsor must independently maintain record accuracy, keep distribution records and handle recall and adverse event communication. The recurring problem the GRZAN regulatory team observes is multiple importers notifying the same device with inconsistent classifications and GMDN codes, leaving the same product with several contradictory profiles in the New Zealand database.

One boundary is often overlooked: an entity that buys devices from a New Zealand sponsor and resells them is not a sponsor. Multiple parallel importers are each sponsors; distributors downstream of the same chain are not. Medsafe expressly lists “New Zealand entities engaged in parallel importing” among its sponsor examples.

• Each importer is a separate sponsor and must notify within 30 working days of becoming a sponsor (reg 6).
• The minimum notification unit is the sponsor-plus-device combination, not the product.
• WAND is free; the real cost of duplication is consistency and governance.
• Reg 5(3) consolidation by kind is possible only under a single sponsor.
• Parallel importers are sponsors; downstream distributors are not.

2. Legal basis

The instruments relevant to multiple importers are set out below.

3. Expert insights

Insight 1: the minimum notification unit is the sponsor-times-device combination. The same device from the same manufacturer, with the same GMDN code and risk classification, appears under multiple importers as multiple parallel records. The consolidation by kind permitted by reg 5(3) works only under one sponsor: the conditions are the same manufacturer, GMDN code and risk classification, and Class I, IIa or IIb; it cannot merge two sponsors’ records. For manufacturers, New Zealand has no single national one-record-per-product entry point. Keeping the database profile consistent can only be achieved by issuing a unified technical data package to every importer, not by relying on one importer’s filing.

Insight 2: s 38(6) exposes multiple importers to the same regulatory action simultaneously. Section 38(6) of the Medicines Act 1981 lets the Director-General exercise the safety evidence power repeatedly against multiple importers or manufacturers for devices of the same kind. Once a model’s safety is questioned, every New Zealand sponsor that imported it may receive a notice and must submit evidence within 45 days; continued sale before the requirement is met is punishable under s 38(8) by up to 6 months imprisonment or a fine not exceeding NZ$5,000. Multi-point distribution neither disperses the risk nor reduces the per-sponsor evidence burden. GRZAN’s judgement: with multiple importers, responsibility for preparing safety documentation usually must sit with the manufacturer, or every sponsor must build its own evidence capability.

Insight 3: the true cost of duplicate notifications is consistency maintenance. Notification is free, but every record is bound by reg 8: once information ceases to be accurate or complete, correction must reach the Director-General within 10 working days. Triggers include a manufacturer or sponsor name change and lapse of certification. If a manufacturer has 5 importers in New Zealand, one name change creates 5 records to update within 10 working days; missing one breaches reg 8, punishable on conviction under reg 14 by a fine not exceeding NZ$500. Add strict liability under s 80: intent need not be proved, and the no-intent plus all-reasonable-steps defence must be notified in writing to the prosecutor within 7 days of service of the summons. Each sponsor bears this independently; there is no defence that someone else already updated.

Insight 4: reg 3(b) can legitimately collapse multiple importers into one. If only one sponsor is wanted, the lawful path is not to designate but to restructure: one New Zealand entity arranges the import and other entities act as its agents. Reg 3(b) expressly excludes persons acting on behalf of another New Zealand resident or business, and Medsafe confirms an agent may handle import and distribution while responsibility stays with the sponsor. The price: all goods and contract flows must be rebuilt around that entity, and if actual practice diverges from the written arrangement, the de facto importer may be treated as the sponsor rather than the nominal one.

4. Practical recommendations

• Map the importer landscape before discussing notification. GRZAN’s first step in multi-importer projects is to obtain the manufacturer’s full New Zealand customer list and assess each against “imports or arranges the import”; that list determines how many parallel records will appear in WAND.
• Issue one technical data package to all importers. Risk classification, GMDN code, UPI (Class III and AIMD) and the exact spelling of manufacturer name and address should be fixed by the manufacturer in writing; GRZAN typically turns this into a one-page New Zealand notification data confirmation letter each importer copies verbatim.
• Control sponsor numbers through reg 3(b) or exclusive distribution terms. Make the importing entity and agency roles explicit in the distribution agreement and align trade document signatories, so the legal form matches actual operations.
• Build a change trigger for every sponsor. On manufacturer name or address changes or classification review outcomes, notify all importers simultaneously and require acknowledgements; GRZAN sets this as the start of the 10 working-day countdown.
• Keep recall and distribution records per sponsor, rehearse jointly. Each sponsor must contact every user it supplied; Medsafe’s recall code organises recalls across 5 supply chain tiers. GRZAN advises one cross-sponsor mock recall annually to verify traceability.

5. Verification checklist

• □ Listed all New Zealand importers and confirmed for each whether it is a sponsor within reg 3
• □ Confirmed every importer has completed its own independent WAND notification
• □ Issued a unified package on risk classification, GMDN code and manufacturer information to all sponsors
• □ Confirmed manufacturer name, address and contact details are identical in every record
• □ Confirmed parallel importers are identified as sponsors and downstream distributors are not registered
• □ Established a reg 8 10 working-day correction trigger for every record
• □ Confirmed each sponsor holds distribution records sufficient for a recall
• □ Confirmed allocation of the 45-day s 38 evidence duty between manufacturer and sponsors is documented
• □ Evaluated whether a reg 3(b) agency arrangement should collapse sponsors to one

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the New Zealand market. Our team coordinates New Zealand sponsor arrangements, import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com