Regulation 5 Information Requirements for WAND Notification in New Zealand

Regulatory information verified as of 29 October 2026

1. Key takeaways

Which fields a WAND (Web Assisted Notification of Devices) notification must contain is decided not by the Medsafe web form but by regulation 5 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325). Having verified the official text, the GRZAN regulatory team confirms that reg 5(1) is structured into three groups, (a)(b)(c), naming seven elements: risk classification, manufacturer name, Sponsor (New Zealand sponsor) name, the Sponsor’s registered office or principal place of business in New Zealand, the manufacturer’s address in New Zealand or overseas, a contact telephone number or email for both parties, and the GMDN product description.

Three additional rules apply. First, only non-exempt Class III and Class AIMD devices must also record a unique product identifier (UPI); Class I, IIa and IIb do not, per reg 5(2); under reg 5(4) the UPI is the trade name or brand name, which the Director-General may require combined with another product identification form. Second, devices of the same manufacturer with the same GMDN code and risk classification, if Class I, IIa or IIb, may be entered by kind under reg 5(3) and reg 5(5); the same kind means substantially similar and designed to be used in the same way and for the same purpose. Third, the GMDN comes from the manufacturer as a 5-digit code.

Regulation 5 covers only what to enter; timing sits in reg 6: a Sponsor must ensure the information reaches the Director-General within 30 working days of becoming Sponsor and submit a reg 7-compliant declaration; where entered information is no longer accurate or complete, a correction must be notified within 10 working days (reg 8). Breaching any of regs 6, 8, 9 or 10 is an offence carrying a fine not exceeding NZ$500 on conviction (reg 14).

The Medsafe website instead refers to 30 calendar days from the device’s first arrival in New Zealand, which does not match the regulations’ 30 working days. GRZAN recommends scheduling internal deadlines on the strictest reading (practical estimate).

One point bears repeating: New Zealand has no pre-market approval, issues no registration certificates, and Medsafe performs no technical review; WAND is a mandatory post-arrival notification database, not a pre-market gate. Notification does not mean Medsafe has assessed the device’s quality, safety, efficacy or performance, and calling notification registration or approval is the most common compliance error in New Zealand.

2. Legal basis

The table below lists the sources verified for this article and the provisions relied on.

3. Expert insights

Insight 1: seven elements within the three-group structure.

Reg 5(1) splits into three groups, becoming seven elements on the entry interface. (a) is risk classification, completed as Class I, IIa, IIb, III or AIMD after determination under regs 11 to 13 and Schedule 2. (b) is party information: the manufacturer’s and Sponsor’s names, the Sponsor’s New Zealand registered office or principal place of business, the manufacturer’s address in New Zealand or overseas, and a contact telephone number or email for both — in substance two names, two addresses and contact details, five elements. (c) is the GMDN product description, provided by the manufacturer as a 5-digit code.

Insight 2: the two addresses are not the same thing.

The address requirements differ: the Sponsor’s address is limited to a New Zealand registered office or principal place of business, the manufacturer’s may be inside or outside New Zealand. This echoes the local presence requirement in reg 3 — a Sponsor must be an importer, exporter or local manufacturer in New Zealand; where an overseas manufacturer supplies directly, the importer is the Sponsor. Entering the overseas manufacturer’s address in the Sponsor field leaves a record conflicting with the statutory definitions.

Insight 3: the UPI is an extra field, only for the two highest classes.

The reg 5(2) trigger is a non-exempt Class III or AIMD device; Class I, IIa and IIb need no UPI, aligning with the reg 11 ordering where only the highest classes carry the extra field. Under reg 5(4) the UPI is the trade name or brand name, which the Director-General may require combined with another product identification form; the value is set on the manufacturer’s side and should be requested before entry.

Insight 4: all three conditions for grouped entry must hold together.

Reg 5(3) and reg 5(5) allow entry by kind if three samenesses plus a class limit all hold: same manufacturer, same GMDN code, same risk classification, and the class limited to Class I, IIa or IIb; if any one fails, grouping is unavailable. Reg 5(5) defines the same kind as substantially similar and designed to be used in the same way and for the same purpose. Class III and AIMD fall outside grouping even where manufacturer and class match, and must be entered item by item. IVDs, for which Medsafe uses a separate IVD classification code, sit outside the literal three conditions; whether grouping applies should be confirmed with Medsafe (practical estimate).

Insight 5: reg 5 and the reg 7 declaration are linked.

Under reg 7(c) the Sponsor declares the reg 6(a) information accurate and complete. Every reg 5 field thus carries signed responsibility: an error touches the offence in reg 14 and the correction duty in reg 8, not merely a correction.

4. Practical recommendations

• GRZAN requires a field responsibility matrix first: risk classification and the GMDN description issued and signed by the manufacturer; the Sponsor name, NZ address and contact details by the Sponsor; both confirm consistency before WAND entry, defusing the reg 7 signing risk in advance.
• Distinguish address fields strictly by party: Sponsor takes the New Zealand registered office or principal place of business, manufacturer its address in New Zealand or overseas; never swap, leave blank or fill a warehouse address (practical estimate).
• Contact details allow a telephone or an email; GRZAN recommends keeping both on file (practical estimate), as Medsafe’s first recall contact is the Sponsor.
• For Class III and AIMD records, obtain the UPI before entry — usually the notification’s bottleneck, and part of the project schedule (practical estimate).
• For Class I, IIa and IIb devices intended for grouping under reg 5(3), prepare an SKU consolidation table on manufacturer + GMDN + class first, then enter accordingly to cut later reg 8 corrections (practical estimate).
• Keep a change trigger list: any change of name, address, classification or GMDN code triggers the 10 working day correction duty (reg 8).

5. Verification checklist

• □ The seven elements of reg 5(1)(a)(b)(c) — classification, both names and addresses, contact details, GMDN description — checked item by item.
• □ The Sponsor name and address are confirmed as a New Zealand entity, per reg 3.
• □ The manufacturer’s address is distinguished as in New Zealand or overseas, not confused with the Sponsor’s.
• □ Contact details provide at least a telephone or an email.
• □ Class III and AIMD records have the UPI entered in addition.
• □ Grouped-entry records meet all conditions: same manufacturer, GMDN, classification, and Class I, IIa or IIb.
• □ The devices have been confirmed as outside the Schedule 1 exemption categories.
• □ Entry completed and the reg 7 declaration submitted within 30 working days of becoming Sponsor.
• □ A change trigger list ensures correction within 10 working days.

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 prepares WAND-compliant evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com