WAND Is a Notification Database, Not an Approval System

1. Key takeaways

WAND is not a registration certificate, nor any approval document or licence. The Medsafe page Explanation of the WAND database (revised 10 May 2011) states: “WAND is not an approval system for medical devices.” and “There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand.” In one line: no premarket approval, no registration certificate, no Medsafe technical review; WAND is a mandatory post-arrival notification database, not a premarket gate. Notification yields a record; Medsafe has neither received nor assessed the product’s quality, safety, effectiveness or performance.

Legally supplied carries two meanings. Officially, What is WAND says, “For medical devices to be legally supplied in New Zealand they must be notified to the WAND database.” Statutorily, SR 2003/325 nowhere prohibits selling an unnotified device; force lies in reg 6 (notification within 30 working days of becoming Sponsor) and reg 8 (correction within 10 working days), breaches under reg 14 fined up to NZ$500. Add two facts: notification occurs after arrival (Medsafe reads the 30 working days as running from first arrival in New Zealand), and the nine Schedule 1 exempt classes, including all IVDs, may be supplied without notification. The sound conclusion: unnotified is not illegally supplied; failure to notify breaches the reg 6 time limit, not a sales ban.

WAND stands for Web Assisted Notification of Devices, established by reg 4 of SR 2003/325: the Director-General must ensure a device database is established and maintained. Made on 17 November 2003 at Wellington by the Governor-General, Dame Silvia Cartwright, by Order in Council, in force from 1 January 2004 (reg 2), current version 7 August 2020. For New Zealand importers, exporters and local manufacturers notification is mandatory; Medsafe’s pages state it is free, with no ongoing fees.

Misreading notification as registration costs more than a concept slip. Reg 10 and reg 7 of the 1984 Regulations prohibit, in both directions, statements implying official endorsement; presenting a WAND record as a certificate is the act most likely to trigger a penalty, though the record involves no fee or waiting.

2. Legal basis

The table consolidates the verified sources.

3. Expert insights

Insight 1: The reg 5 field design shows this is not an approval process. If WAND were an approval system, its fields would include technical documentation, clinical evidence and quality system certificates, with a review step. In reality reg 5(1) requires only 7 items: (1) the device’s risk classification; (2) the manufacturer’s name; (3) the Sponsor’s name; (4) the Sponsor’s registered office or principal place of business address in New Zealand; (5) the manufacturer’s registered office or principal place of business address (inside or outside New Zealand); (6) contact telephone or email for both parties; and (7) the nominated product description, the GMDN description (the regulation writes GMDNS; quotations must preserve that spelling, running text uses GMDN). For Class III and AIMD, reg 5(2) additionally requires the unique product identifier (UPI); Class I, IIa and IIb do not, and that is the only additional requirement. These fields are identification data only: no approve-or-reject slot, nothing to review.

Insight 2: The divergent time-limit readings show an intake, not an acceptance process. Reg 6 requires information and declaration within 30 working days of becoming Sponsor; What is WAND uses 30 calendar days; the Regulatory requirements page states 30 working days from first arrival in New Zealand. These are inconsistencies inside Medsafe’s own website, and because no acceptance step exists they have never needed correction: no acceptance receipt, no deficiency notice, no date of approval. The continuing duty sits in reg 8: when information ceases to be accurate or complete, correction is due within 10 working days.

Insight 3: Liability attaches to the Sponsor, not to the product. Reg 14 makes breach of any of regs 6, 8, 9 or 10 an offence fined up to NZ$500 on conviction. The amount is small, but it targets one subject precisely: the Sponsor. The legislator punishes failing to put accurate, timely information into the database and stand behind it, not putting an unsafe product on the market; the latter is handled by s 38, with imprisonment up to 6 months or a fine not exceeding NZ$5,000. The two lines run in parallel, which is why completed notification has never meant safe sale.

Insight 4: The record is non-transferable, confirming it is not a right. A WAND record is bound to a specific Sponsor; changing Sponsor requires a new record and disposal of the old one. A certificate would have a statutory transfer framework; in reality the record attaches to the person identified under reg 3, remaining a notification by a particular Sponsor for a particular device over a particular period.

4. Practical recommendations

• Standardise external wording. GRZAN writes the standard usage WAND notification record into the client glossary and bans terms such as registration certificate, market access licence or official certification from marketing material, tenders and distributor handbooks. Costs nothing, removes the misunderstanding immediately.
• Turn the reg 10 and reg 7 prohibitions into red-line phrasing. Reg 10 and reg 7 close off official endorsement claims from both directions. GRZAN reviews confine WAND records to internal compliance contexts; external material says instead that New Zealand WAND notification has been completed.
• Build change triggers for reg 8. Manufacturer name changes, Sponsor or address changes and certificate lapses all make records inaccurate. Set field-level alerts in ERP and quality systems, correcting within 10 working days of triggering.
• Do not let free notification hide ongoing cost, or treat a Medsafe service fee as a filing fee. Notification is free, with no annual fee and no premarket review fee, as Medsafe’s pages state. In the Medsafe Schedule of Fees (Revised 6 July 2026, GST inclusive), the only device-related charge is regulatory statements issued to foreign governments, NZ$186 each: an administrative fee for issuing documents, appearing nowhere in the Medicines Regulations 1984 and not a NZ$186 device market-entry fee. GRZAN’s experience is that beyond a certain scale, WAND record maintenance occupies part of a dedicated role (a practical estimate).
• Retain full evidence of completed notification. Submission records, timestamps and the reg 7 declaration copy must remain retrievable on challenge; they are the only proof that the reg 6 duty was met.

5. Verification checklist

• □ The glossary bars describing WAND records as registration certificates or approval documents
• □ Notification is complete and a WAND record pointing to the product exists
• □ All 7 items of reg 5(1) information checked (classification, both names, both addresses, both contacts, GMDN description)
• □ Class III and AIMD products confirmed to have the UPI entered
• □ Reg 7 declaration copy and submission timestamp retained
• □ Reg 8 change triggers set, covering the 10 working day deadline
• □ Promotional material screened for official approval and Medsafe certification claims
• □ Notification confirmed free, no annual fee, no premarket review fee; the fee schedule’s only device item, NZ$186, checked as a regulatory-statement service fee for foreign governments, not a filing fee

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