Who Must Notify: Sponsor Status and Exempt Devices

1. Key takeaways

The WAND notification duty in New Zealand turns on two conditions: the notifier must be a Sponsor (the New Zealand sponsor) and the device must not be an exempt device.

The subject condition appears in reg 3(a) of the 2003 Regulations (SR 2003/325): a person in New Zealand who exports or arranges exportation of the device, who imports or arranges importation, or who manufactures or arranges manufacture for supply. Reg 3(b) excludes persons acting on behalf of a New Zealand resident or a person carrying on business in New Zealand. Those that must notify are importers, exporters and local manufacturers; those that need not include retailers, downstream users such as hospitals, pure agents and carriers.

The object condition sits in reg 5(1): the database information targets each device that is not an exempt medical device. The exempt list sits in Schedule 1, 9 classes from (a) to (i). The notification acts are reg 6 (within 30 working days) and reg 7 (declaration).

Lawfully supplied must be read on two levels: Medsafe’s homepage states, For medical devices to be legally supplied in New Zealand they must be notified to the WAND database.; but SR 2003/325 sets no prohibition on sale without notification, enforcement resting on the reg 6 and 8 time-limit duties, breaches under reg 14 punishable by a fine up to NZ$500. On Medsafe’s reading, notification occurs after first arrival in New Zealand, not as a premarket precondition; the nine Schedule 1 classes, including all IVDs, may be lawfully supplied without notification. Unnotified does not mean illegally supplied.

Only medical devices enter the system. The sole source of the definition is s 3A of the Medicines Act 1981, with the s 4 therapeutic purpose provision; reg 3 of the 2003 Regulations likewise provides that medical device has the same meaning as it has in section 3A of the Act.

2. Legal basis

The table maps each obligation element onto its verified source.

The nine Schedule 1 exempt classes (verified class by class): (a) devices that are also medicines within s 3(1) of the Medicines Act 1981 (except where rule 13(2) of Schedule 2 applies); (b) devices made at the request of a registered health professional to design features specified by that professional, for the sole use of a particular patient; (c) devices supplied to a medical or dental practitioner for the particular patient; (d) devices imported and under New Zealand Customs control pending export to another country; (e) devices commonly known as in vitro diagnostic devices, for use only within a particular laboratory; (f) diagnostic devices manufactured in a laboratory for use in another laboratory (LDTs); (g) devices imported by a person solely for their own use; (h) devices imported for a clinical trial; (i) devices of a class declared exempt by the Director-General by notice in the Gazette.

3. Expert insights

Insight 1: Subject and object are two independent judgement lines. The common error merges them. An importer of laboratory-developed test products is a Sponsor (reg 3(a)(ii)), but the products fall within Schedule 1(f), so no duty arises; conversely, a device outside the nine exemptions imported by an individual solely for own use (Schedule 1(g)) also generates no duty. GRZAN recommends a two-column table per consignment, entering the workflow only when both answer yes.

Insight 2: Exemption lifts the notification duty, not all duties. Schedule 1’s wording is exempt medical device; the reg 5(1) entry and reg 6 notification duties therefore do not apply to the device. The safety requirements of s 38 of the Medicines Act 1981, labelling under reg 12(4) of the 1984 Regulations, and advertising and information duties under regs 10, 11 and 25 do not condition on exemption status. Clinical trial devices (Schedule 1(h)) need no notification, but their instructions for use, safety responsibilities and post-market handling remain subject to current rules.

Insight 3: Exporters are inside the subject class too. Reg 3(a)(i) places a person in New Zealand who exports or arranges exportation within the Sponsor definition, so a business manufacturing entirely for export equally bears the reg 6 duty. This is often misread as no notification needed for export-only products.

Insight 4: Exempt class (i) is alive, and IVDs come from it. Schedule 1(i) authorises the Director-General to declare exempt classes by Gazette notice, so item (i) is an open entrance, not a static list. The IVD exemption arises this way: the Director-General made the Exemption Medical Devices (In Vitro Diagnostic Devices) Notice (No. 1) 2003 on 12 December 2003, in force 1 January 2004. Medsafe recognises no IVD risk grading model, using uniformly the IVD code with 5-digit GMDN codes.

4. Practical recommendations

• Characterise first, identify the person second, test exemption last: s 3A and s 4 determine whether the product is a medical device; regs 3(a) and 3(b) determine who the Sponsor is; Schedule 1(a)–(i) determines whether it is exempt. Notification starts only when all three pass.
• Build an exemption determination trail for every SKU: record each SKU’s exemption class letter and reasoning in the product register, so the company can state which class applies and why.
• Schedule notification on the strictest reading. Regulation 6 states 30 working days from becoming Sponsor; Medsafe’s own pages are inconsistent, the WAND homepage stating 30 calendar days and the regulatory requirements page 30 working days from first arrival, the statutory reading being reg 6. GRZAN recommends internal deadlines on the strictest reading, 30 calendar days from first arrival (a practical estimate).
• Keep exempt devices inside post-market management; recall, adverse event reporting and distribution record duties do not disappear with exemption; initial death or serious injury reports are due as soon as possible and within 10 calendar days via devices@health.govt.nz.
• Review exempt class (i) periodically. Gazette notices may adjust exempt classes; GRZAN recommends adding legislation.govt.nz records and Medsafe’s exempt device page to the review list (a practical estimate).

5. Verification checklist

• □ Product characterisation is complete under s 3A and s 4, basis recorded
• □ Reg 3(a) confirms the company as Sponsor, excluding the reg 3(b) agent case
• □ Schedule 1(a)–(i) has been compared class by class, exemptions recorded by letter
• □ Exemption is confirmed to lift only the notification duty; s 38, labelling and advertising duties still apply
• □ IVD products use the IVD code and 5-digit GMDN codes; export-only businesses have confirmed reg 3(a)(i) likewise creates Sponsor status
• □ The notification time limit is set on the strictest reading, with a clear start point
• □ The 10 calendar day deadline for death or serious injury reports and the devices@health.govt.nz channel are in post-market processes
• □ External material describes 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