Definition and Responsibilities of the Sponsor in New Zealand

1. Key takeaways

In New Zealand’s device system, the Sponsor (New Zealand sponsor) is the only legally pursued subject. The statutory definition appears in reg 3 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325): in relation to a medical device, the Sponsor means a person in New Zealand who exports or arranges exportation of the device; who imports or arranges importation; or who manufactures the device, or arranges another person to manufacture it, for supply in New Zealand or elsewhere.

Medsafe’s device definition page states: The Sponsor is the New Zealand entity - importer, exporter or local manufacturer - that has the legal responsibility for a medical device supplied in New Zealand.

The Sponsor’s duties span the whole product life cycle, falling almost entirely on the Sponsor, not the overseas maker: notification (reg 6, 30 working days), declaration (reg 7), correction (reg 8, 10 working days), procedures (reg 9), prohibited statements (reg 10), device safety (Act s 38), labelling (reg 12(4) of the 1984 Regulations), advertising (Act Part 4), recall and adverse event reporting. Reg 14 also confines criminal liability to the Sponsor: breach of any of regs 6, 8, 9 or 10 is an offence fined up to NZ$500.

2. Legal basis

1. The Sponsor definition (verbatim)

• Instrument: Medicines (Database of Medical Devices) Regulations 2003
• Number: SR 2003/325
• Made: 17 November 2003 (Order in Council, Wellington); in force: 1 January 2004 (reg 2)
• Provision: reg 3 — sponsor, in relation to a medical device,— (a) means— (i) a person in New Zealand who exports, or arranges the exportation of, the device from New Zealand; (ii) a person in New Zealand who imports, or arranges the importation of, the device into New Zealand; (iii) a person in New Zealand who manufactures the device in New Zealand, or arranges for another person to manufacture the device in New Zealand, for supply (whether in New Zealand or elsewhere); but (b) does not include a person who— (i) exports, imports, or manufactures a device; or (ii) arranges for the exportation, importation, or manufacture of a device,— on behalf of another person who, at the time of the exportation, importation, manufacture, or making of the arrangements, is a resident of, or is carrying on business in, New Zealand.

Reg 3(b) is the exclusion: a person acting on behalf of another who, at the relevant time, is a resident of, or is carrying on business in, New Zealand does not become a Sponsor.

2. Sponsor duties and penalty provisions

3. Official Medsafe guidance

• Definition of a medical device / Definition of a Sponsor, https://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp, revised 15 January 2015
• Regulatory Requirements, https://www.medsafe.govt.nz/regulatory/DevicesNew/3-6RegulatoryRequirements.asp, revised 10 May 2011

3. Expert insights

Insight 1: Sponsor is a status, not a qualification. Reg 3 defines the status by conduct: whoever performs one of the three actions is the Sponsor — no application, approval or certificate. This differs from designation-based roles like the EU authorised representative or US Agent. Consequence: a New Zealand importer may become a Sponsor unknowingly, with the 30 working day clock already running.

Insight 2: The reg 3(b) exclusion keeps agents outside. Freight forwarders, customs brokers and third-party logistics providers acting purely on behalf of a New Zealand resident or person carrying on business there do not become Sponsors. This is often misread as permission to appoint an agent as Sponsor. In reality the represented party is itself the Sponsor; where an overseas manufacturer appoints a New Zealand agent to import, the agent escapes Sponsor status only if the beneficiary of the acts is itself resident in or carrying on business in New Zealand.

Insight 3: The fine is small, but the real risk is not the fine. The reg 14 ceiling of NZ$500 is often read as negligible cost of breach. GRZAN’s reading: it is only the lightest layer. Real exposure comes from s 38: where the Director-General has reason to believe a device may be unsafe, written notice may require evidence, with safety evidence due within 45 days; selling before the requirement is met, or before a satisfactory safety notice is received, attracts s 38(8), up to 6 months imprisonment or a fine not exceeding NZ$5,000. Also, s 79 provides that where a body corporate commits an offence, every director and every person concerned in management is guilty of the same offence if the act was authorised, permitted or consented to by that person, or that person knew and failed to take reasonable steps to prevent it; s 80 makes such prosecutions strict liability, with no proof of intent needed.

Insight 4: The Sponsor’s declaration is not a formality signature. Reg 7 requires the Sponsor or an employee to declare three matters: (a) the product is a device in the statutory sense and correctly classified; (b) the Sponsor recommends the product only by intended purpose; (c) the information supplied under reg 6(a) is accurate and complete. These declarations press characterisation, classification and information truthfulness onto the Sponsor, and because Schedule 2 has 22 classification rules while Medsafe issues no rulings, the Sponsor must explain the classification basis unaided.

4. Practical recommendations

• Determine status first, then schedule notification. Check each shipment against the three reg 3 actions before despatch, confirm in writing who the Sponsor is, and start the 30 working day countdown then. Medsafe’s pages are inconsistent, the WAND homepage stating 30 calendar days and the regulatory requirements page 30 working days from first arrival, while reg 6 is the statutory reading. Schedule to the strictest reading, 30 calendar days from first arrival (a practical estimate).
• Write the Sponsor duties as an actionable checklist with named owners. At minimum it covers notification and declaration, the 10 working day correction, procedure documents (reg 9), prohibited statement review (reg 10), label checks (1984 regs 12(4)), advertising review (Act Part 4 and regs 10, 11), recall procedures, adverse event reporting and distribution records.
• Fix the information channel between Sponsor and overseas manufacturer in a written agreement. The reg 8 correction duty triggers when information ceases to be accurate or complete, usually on the maker’s side, through name changes, certificate lapses or GMDN changes. The agreement should provide for the manufacturer’s immediate notification duty (the time limit is a practical estimate).
• Do not add a separate local-language rendering of the word Sponsor. New Zealand issues no device registration certificate and the Sponsor holds no licence; loose wording carries inconsistency into contracts and materials.

5. Verification checklist

• □ Sponsor status determined item by item under reg 3(a)(i)(ii)(iii) and recorded in writing
• □ The reg 3(b) exclusion applied, with no mistaken assumption of agent-held Sponsor status
• □ A New Zealand registered office or principal place of business address is available for the Sponsor (reg 5(1)(b)(i))
• □ The notification countdown is set on the strictest reading, with a clear start point
• □ The reg 7 declarations have internal review records, classification traceable to specific Schedule 2 rules
• □ The 10 working day reg 8 correction mechanism is embedded in roles and system reminders
• □ Labels checked against the manufacturer or New Zealand distributor name requirement of reg 12(4)
• □ External material adds no local local rendering of Sponsor and treats notification as neither registration nor approval

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