WAND Notification Process: Required Fields, Declarations and Group Entries

Regulatory information verified as of October 29, 2026.

1. Key takeaways

All mandatory fields of a WAND notification are set out in regulation 5 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325), and there are only three: the risk classification; the names, addresses and contact details of the manufacturer and of the Sponsor (New Zealand sponsor); and a description of the device in terms of the GMDN system. After verifying the official provisions, GRZAN can confirm that the field volume of a New Zealand notification is of an entirely different order from the technical documentation demanded by the EU or the US.

Two additional rules sit on top of this base. First, regulation 5(2) imposes an extra requirement for non-exempt Class III and Class AIMD devices: a unique product identifier (UPI) must be entered. Regulation 5(4) defines the UPI as the trade name or brand name, and the Director-General may require it to be combined with a form of product identification. Second, regulation 5(3) allows a group entry by category, instead of device-by-device entry, where four conditions are met: the same manufacturer, the same GMDN code, the same risk classification, and Class I, Class IIa or Class IIb.

The notification must be made by the Sponsor (New Zealand sponsor) in person or by an employee of the Sponsor, and the submission includes, alongside the information, a declaration complying with regulation 7 covering three matters: that the product is a device in the legal sense and is correctly classified; that the Sponsor recommends the product only for its intended purpose; and that the information provided is accurate and complete.

On account application and system operation steps, one point must be made explicit: neither SR 2003/325 nor the verified Medsafe pages specify a standard processing time for account applications, a number of days for approval, or an account approval workflow. GRZAN does not quote any turnaround figure that has not been officially verified. The WAND online system is provided by Medsafe, and the officially designated contact email for system issues is devices@health.govt.nz.

2. Legal basis

Official sources: https://www.legislation.govt.nz/regulation/public/2003/0325/latest/ ; https://www.medsafe.govt.nz/regulatory/DevicesNew/3WAND.asp ; https://www.medsafe.govt.nz/regulatory/DevicesNew/3-8MDExempt.asp

3. Expert insights

Insight 1: regulation 5(1)(b) is the layer most often filled in wrongly. Regulation 5(1)(b) asks for more than names: it requires the names plus three items of supporting information — the address of the Sponsor’s registered office or principal place of business in New Zealand, the address of the manufacturer’s registered office or principal place of business (whether in New Zealand or overseas), and a telephone number or email address for both. The statutory address test is the registered office or principal place of business, not a warehouse address, a delivery address or a customer service address. An overseas manufacturer may give an overseas address; the provision says so expressly — whether in New Zealand or overseas.

Insight 2: the UPI is far looser than the UDI. Regulation 5(4) defines the unique product identifier as the trade name or brand name, with an additional form of product identification required only if the Director-General asks for one. This differs from the EU MDR’s UDI system. When building a multi-market data package, do not treat the EU UDI-DI as mandatory content for the UPI here; first confirm whether the Director-General has imposed additional requirements for the device class in question. The UPI applies strictly to non-exempt Class III and Class AIMD devices; Class I, IIa and IIb are outside its scope.

Insight 3: group entry is a lawful cost-saving channel, but with four hard gates. Regulation 5(3) permits entry by category rather than by each device, provided the manufacturer, GMDN code and risk classification are the same and the class is I, IIa or IIb. Regulation 5(5) further defines devices of the same kind as requiring substantial similarity and the same designed purpose and manner of use. All four plus two conditions must be satisfied together; if any one fails, separate entries are required.

Insight 4: common rejection reasons are experience-based, not a statutory list. Neither Medsafe nor the regulations publish a list of rejection reasons. The high-frequency issues GRZAN has compiled from project experience include: a GMDN code that does not match the actual product description; a risk classification that conflicts with the intended use implied by the GMDN term; a Sponsor address given as an overseas or non-registered-office address; a manufacturer record not yet established in WAND; and a declarant whose employee status under the Sponsor does not check out. All of these are (practical estimate) experience-based summaries, not official statutory requirements, and companies should not infer review standards from them.

4. Practical recommendations

• GRZAN recommends a field pre-check before formal entry: break the three field groups of reg 5(1) into a checklist and compare the manufacturer’s raw data against the proposed entries item by item, confirming in particular that the 5-digit GMDN code and its English description have been obtained as a pair.
• GRZAN handles manufacturer onboarding as a separate step in project delivery. The manufacturer record in WAND is a prerequisite for entry; if the overseas manufacturer has never appeared in New Zealand before, arrange the record early rather than getting stuck at the last mile of entry. No official source states the onboarding turnaround, so no day count should be promised externally.
• For Class III and AIMD products, confirm in advance whether the Director-General requires the UPI as a trade name plus product identification combination, to avoid a second correction. Once triggered, a correction falls under the 10 working day duty in reg 8.
• The declaration must be made by the Sponsor or an employee of the Sponsor; GRZAN recommends keeping written evidence of the declarant’s identity and authority. Item (a) of the reg 7 declaration points directly at classification correctness — by signing, the Sponsor bears the legal consequences of its own classification judgement, since Medsafe does not rule on classifications.
• System operation issues should go through the officially published devices@health.govt.nz channel, with the correspondence archived as operating evidence of the compliance procedure under reg 9.

5. Verification checklist

• □ Confirmed that the device to be notified does not fall within a Schedule 1 exemption of SR 2003/325
• □ Risk classification determined, with the basis recorded (the specific Schedule 2 rule number)
• □ Sponsor name and New Zealand registered office / principal place of business address ready
• □ Manufacturer name and its registered office / principal place of business address ready (an overseas address is acceptable)
• □ Telephone or email contact for both Sponsor and manufacturer ready
• □ GMDN code and product description obtained; IVDs carry a 5-digit code
• □ For Class III / AIMD, the UPI approach confirmed (trade or brand name, and whether the Director-General requires an additional identification form)
• □ If a group entry is planned, the four conditions of reg 5(3) and the two conditions of reg 5(5) verified one by one
• □ The three declarations of reg 7 confirmed by the Sponsor or an employee, with the declarant’s identity traceable
• □ Procedures under reg 9 established and documented

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 WAND entries and sponsor registration, prepares reference-market evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com