WAND Notification Fees: What New Zealand Actually Charges

1. Key takeaways

Regulatory information verified as of 29 October 2026. Notifying a medical device to the New Zealand WAND database attracts no official charge: no filing fee, no pre-market assessment fee, no annual fee, no maintenance fee. GRZAN confirms three independent evidence layers.

Layer one is statutory absence: reg 61 (Fees) of the Medicines Regulations 1984 (SR 1984/143), the fee-setting instrument under the Medicines Act 1981, provides: Schedule 5A licence fees (1); $9,000 (2); $122,625 (3); $79,877 (4); $5,731 (5); $1,730 (5A); $42,601 (5B); $85,202 (6); $79,877 (7); $9,843 (8); $60 (9); $600 (10). All twelve concern medicines or related products; not one concerns medical devices. The current text (as at 10 July 2026) has zero hits for Regulatory Statements and Foreign Government.

Layer two is Medsafe’s Schedule of Fees Payable under the Medicines Act 1981, revised 6 July 2026, all fees GST inclusive. The only device-related item is: Medical Devices – Regulatory Statements to Foreign Governments (per statement) NZ$186 — a per-document service fee for statements or export certificates Medsafe issues to foreign governments, neither a WAND notification fee nor a registration fee. The figure is current per the 6 July 2026 edition, incorporating the Medicines (Fees) Amendment Regulations 2026 (SL 2026/164, made 2 June 2026, effective 3 July 2026). Two cautions: never call NZ$186 a device application fee, and never cite reg 61 as its source.

Layer three is WAND itself: notification is free with no ongoing fees, and WAND is not an approval system. The real cost is labour and systems: qualification, risk classification, GMDN selection, field entry, change maintenance, and the s 38 dossier. A local sponsor arrangement, where no New Zealand entity exists, is a commercial service fee, not an official charge.

• WAND carries no official fee: no filing, assessment, annual or maintenance fees.
• Reg 61’s twelve fee subsections cover no medical devices.
• The only device-related official fee is NZ$186 per regulatory statement to a foreign government.
• Source: Medsafe’s Schedule of Fees, revised 6 July 2026, incorporating SL 2026/164.
• Real costs are labour, systems and sponsor arrangements — commercial, not official.

2. Legal basis

The instruments relevant to notification fees are set out below.

3. Expert insights

Insight 1: free access is the inevitable result of system design, not a concession. WAND is not an approval system; with no assessment step there is no fee-worthy workload. The reg 5 fields — risk classification, manufacturer and sponsor names, addresses and contacts, GMDN description — are identification data only, not substantively verified. Equating free with a low barrier is safe; equating it with zero cost is a budgeting error.

Insight 2: keep the three evidence layers and the source of NZ$186 separate. Statutorily, reg 61 lists twelve fee subsections, none for devices — the basis for no filing, assessment or annual fees. NZ$186 exists only at webpage level, not in reg 61 or Schedule 5A. GRZAN advises citing the layers separately, noting the source as Medsafe’s Schedule of Fees of 6 July 2026 (incorporating SL 2026/164). For contrast: the reg 61(5A) $1,730 and (5B) $42,601 inserted by SL 2026/164 serve the medicines verification pathway of the Medicines Amendment Act 2025 (s 22C / s 22D), unrelated to devices; no amendment since 2023 has concerned devices. Across the legislative active period of 2024 to 2026, the WAND duty provisions (SR 2003/325 regs 5 to 14) and the device-related provisions (SR 1984/143 regs 4(6), 10, 11(4), 12(4), 17, 18, 25, 50, 62) have not moved at all.

Insight 3: the real cost is being ready to produce evidence at any time, not the moment of submission. New Zealand moved pre-market safety argumentation to a post-market, passively triggered duty: where the Director-General has reason to believe a device may be unsafe under s 38, a written notice may require the importer or manufacturer to submit evidence within 45 days; continued sale before the requirement is met is punishable under s 38(8) by up to 6 months imprisonment or NZ$5,000. Dossiers must be retrievable year-round; a permanently ready evidence package for a free action is the principal cost.

Insight 4: four third-party fee misconceptions need identifying. First, packaging NZ$186 as a device application fee. Second, claiming Medsafe charges annual or maintenance fees for WAND records. Third, claiming an official expedited channel with a surcharge. Fourth, mixing representative or consulting fees with official charges on one quotation. The first three have no basis in official sources; the fourth is commercial, to itemise and label in quotations.

4. Practical recommendations

• Separate official fees from professional service fees on every budget. GRZAN’s New Zealand quotations put the official charges line at 0 (export certificates itemised at NZ$186 per statement), service fees quoted and labelled separately.
• Front-load effort into qualification, classification and GMDN code selection. These determine every later field’s correctness and how often reg 8 corrections trigger; getting it right once is far cheaper.
• Build a standing evidence package for the s 38 45-day window. GRZAN advises assembling the risk analysis, clinical evaluation, overseas authorisations and vigilance data into a submission-ready dossier, with a New Zealand contact for notices.
• Trace every official fee in third-party quotations to its source. For any fee claimed to be charged by Medsafe or the Ministry of Health, require the schedule item name and source page; anything untraceable is reclassified as commercial.
• Assess long-term maintenance workload by product line size. Record counts, change frequency and SKU iteration speed determine effort; beyond a certain size, WAND maintenance settles into a designated role’s routine (practical estimate, not an official requirement).

5. Verification checklist

• □ Confirmed WAND carries no official fee; the quotation’s official charges line is 0
• □ Checked Medsafe’s fees schedule revision date is 6 July 2026 and incorporates SL 2026/164 (made 2026-06-02, effective 2026-07-03)
• □ Confirmed NZ$186 is a per-document service fee for statements to foreign governments, not a notification or registration fee
• □ Confirmed none of reg 61’s twelve fee subsections concerns medical devices
• □ No mismatched wording such as regulation 61 charging NZD 186 for device statements appears externally
• □ Every official fee in third-party quotations traced to a fees schedule item
• □ Local sponsor arrangement fees itemised and labelled as commercial service fees
• □ Standing technical dossier supports the 45-day s 38 evidence window
• □ Long-term maintenance workload is in the annual staffing budget (practical estimate)
• □ Confirmed no annual fees, no pre-market assessment fees, no expedited channel fees

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 coordinates New Zealand sponsor arrangements, import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com