Overseas Manufacturers and the New Zealand Sponsor Requirement

1. Key takeaways

An overseas manufacturer cannot itself become the Sponsor (the New Zealand sponsor), nor complete WAND notification itself. The statutory definition appears in reg 3(a) of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325), and all three identities are prefixed by being a person in New Zealand: exporting or arranging exportation, importing or arranging importation, or manufacturing or arranging manufacture for supply. An overseas manufacturer cannot be the notifying party to WAND; the Sponsor must have a New Zealand entity presence. Where an overseas manufacturer supplies New Zealand directly, the New Zealand importer performing the import is the Sponsor. Medsafe’s official guidance states the same: Where an overseas company supplies directly to New Zealand, the importer is the sponsor.

The local-presence requirement is concrete and verifiable, not a statement of principle. Reg 5(1)(b)(i) of the 2003 Regulations requires the database information to include the address of the registered office or principal place of business in New Zealand of the sponsor, together with the manufacturer’s registered office or principal place of business address (whether in New Zealand or overseas) and contact telephone numbers or email addresses for both parties. A WAND record must therefore simultaneously show a New Zealand Sponsor address and a manufacturer address that may be anywhere.

The overseas manufacturer is not idle. Although not the Sponsor, it is the source of the information and evidence the Sponsor needs to perform: risk classification, GMDN codes, the unique product identifier (UPI) for Class III and AIMD devices, intended purpose, safety evidence, and technical support for recalls and adverse events.

2. Legal basis

The table below maps each matter onto the verified instrument, number and provision.

3. Expert insights

Insight 1: The reg 3(b) exclusion closes the appoint-an-agent route. Many overseas manufacturers first look for a New Zealand compliance services company to serve as the Sponsor. Reg 3(b) excludes persons acting on behalf of another person who is a New Zealand resident or carrying on business in New Zealand: if the services company acts purely as an import agent, the represented party is the Sponsor; if there is no such New Zealand represented party, the services company must itself actually perform or arrange the import before falling within reg 3(a)(ii). A nominal Sponsor therefore has no legal footing, and the Sponsor named in WAND records must be the party genuinely performing import, export or local manufacture arrangements.

Insight 2: Local presence lives in an address field, not in a certificate. New Zealand has no Sponsor registration certificate and no Sponsor qualification review. Presence is expressed through the reg 5 address and contact fields: the Sponsor must have a New Zealand registered office or principal place of business address and a reachable telephone or email. This differs from the EU authorised representative, which is registered with authorities, and the UK RP, which is held in MHRA records: in New Zealand, presence is recorded in notification data, not approved.

Insight 3: Multiple importers mean multiple Sponsors. Reg 3 defines the Sponsor by reference to the person, not the device. If the same product of the same manufacturer has two New Zealand importers, there are two Sponsors, each independently bearing the reg 6 notification duty and the reg 8 correction duty, each filing its own reg 7 declaration. The consequence for an overseas manufacturer’s channel management is direct: changing or adding distributors creates new notification duties and new record maintenance obligations.

Insight 4: The overseas manufacturer’s compliance role is information source plus technical endorsement. Medsafe issues no risk classification rulings; classification responsibility sits between Sponsor and manufacturer, with 22 rules in Schedule 2 and a judgement method that works backwards from rule 22 by exclusion. GMDN codes (IVDs use 5-digit codes) are supplied by the manufacturer. The s 38 safety evidence notice may be issued to the importer or the manufacturer, and evidence is due within 45 days of receipt. The overseas manufacturer’s practical role is therefore to supply accurate, verifiable classification, naming, UPI and intended purpose information to the Sponsor, and to carry the technical evidential burden when Medsafe opens a safety enquiry.

4. Practical recommendations

• State Sponsor allocation and cooperation duties in distribution agreements. GRZAN recommends making explicit that the New Zealand importer is the Sponsor and completes WAND notification, and that the overseas manufacturer supplies risk classification bases, GMDN codes, UPI, intended purpose statements and change notifications. GRZAN also requires a named manufacturer contact, so the Sponsor is not left without an information source inside the 10 working day reg 8 window.
• Create an immediate manufacturer-change-to-Sponsor-correction channel. Typical reg 8 triggers include manufacturer name changes, certificate lapses, and changes to risk classification or GMDN codes. Agree that the manufacturer gives written notice immediately on confirming a change, with the Sponsor then running its own 10 working day countdown (the specific notice time limit is a practical estimate).
• Do not rely on nominal Sponsor arrangements. GRZAN’s reading of regs 3(a) and 3(b) is that a party not genuinely performing import, export or local manufacture arrangements can hardly hold Sponsor status under reg 3; once Medsafe or a purchaser traces responsibility, records and the actual responsible party will diverge.
• Fix the channel list early. Every new importer generates an independent Sponsor and an independent notification. GRZAN recommends a channel policy under which supply to a new distributor is released only after its Sponsor status and completed notification are confirmed (this process design is a practical estimate).
• Check labels in the same pass. Reg 12(4) of the 1984 Regulations requires the device to bear the manufacturer’s name or the name of its New Zealand distributor; the overseas manufacturer should confirm with the Sponsor how this field appears at the artwork stage, before leaving the factory.

5. Verification checklist

• □ Written documents confirm that the New Zealand party performing import is the Sponsor and the overseas manufacturer does not act as Sponsor
• □ The Sponsor’s New Zealand registered office or principal place of business address is confirmed as enterable in WAND (reg 5(1)(b)(i))
• □ Contact telephone or email for both Sponsor and manufacturer is complete (reg 5(1)(b)(iii))
• □ Nominal Sponsor and agent-held arrangements are excluded, with reg 3(b) assessed
• □ Each New Zealand importer has separately confirmed Sponsor status and separately completed notification
• □ The manufacturer has supplied risk classification bases and GMDN codes; UPI is supplied for Class III and AIMD
• □ The manufacturer change notification mechanism is in the agreement, and the Sponsor’s internal 10 working day correction process is ready
• □ Labels bear the manufacturer’s name or the name of its New Zealand distributor

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 manages Medsafe sponsor obligations and WAND entry requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com