Change of Sponsor and the Non-Transferability of WAND Records

1. Key takeaways

Regulatory information verified as of 29 October 2026. WAND (Web Assisted Notification of Devices) records cannot be transferred. A notification belongs exclusively to the sponsor-plus-device combination. On a sponsor change, the old record cannot be handed over; the new sponsor must create its own record, and the original sponsor should set its status to Obsolete once it stops supplying.

The changeover generates no fees — WAND notification is free with no ongoing fees, as Medsafe states officially. The real time pressure comes from reg 6 of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325): the new sponsor must complete notification and the reg 7 declaration within 30 working days of becoming the sponsor of the device. The clock starts when the new entity actually becomes sponsor, regardless of whether the old record has been dealt with.

Medsafe designates the administrative channels: sponsor detail changes use the Sponsor Details Update Form; WAND administrator (account contact) changes use the WAND Administrator Details Update Form; both go to devices@health.govt.nz or to Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145.

GRZAN repeatedly clarifies one scenario in projects: a person or organisation that buys devices from a New Zealand sponsor and resells them is not a sponsor. An entity becomes a sponsor only when it imports the device itself or arranges its import. Switching distributors is not necessarily a sponsor change; a new distributor that clears the goods on its own account necessarily adds a new sponsor.

• WAND records are not transferable: a new sponsor files a new notification within 30 working days (reg 6).
• The outgoing sponsor sets its record status to Obsolete after stopping supply.
• Changeover involves no official fees; WAND is free with no ongoing fees.
• Sponsor detail changes use the Sponsor Details Update Form; administrator changes use the WAND Administrator Details Update Form, sent to devices@health.govt.nz or PO Box 5013, Wellington 6145.
• Buying and reselling from a New Zealand sponsor does not make an entity a sponsor.

2. Legal basis

The instruments relevant to a change of sponsor are set out below.

3. Expert insights

Insight 1: non-transferability follows from the structure of reg 3, not system design. Reg 3 defines the sponsor as the person who imports the device into New Zealand or arranges its import — a concept that changes with the importing entity: a new importer means a new sponsor, with new duties and a new database record. The field reg 5(1)(b)(i) requires is the sponsor’s New Zealand registered office or principal place of business address, and that field alone means the record cannot exist independently of the entity. Once understood, it is clear why transfer fails both technically and legally: a transferred record would carry two sponsor addresses in one entry, conflicting with reg 5.

Insight 2: the responsibility vacuum during changeover is the new sponsor’s most expensive risk. The reg 6 duty starts when the entity becomes sponsor, but exposure begins the moment it takes over the product. Section 38(2) of the Medicines Act 1981 empowers the Director-General to issue a safety evidence notice to an importer or manufacturer, with evidence due within 45 days (s 38(3)); selling before the requirement is met is punishable under s 38(8) by up to 6 months imprisonment or a fine not exceeding NZ$5,000. New sponsors often sell before obtaining the original sponsor’s technical documentation. GRZAN’s judgement: the most important item in the handover is not the WAND record itself but the transferability of the s 38 evidence capability.

Insight 3: s 79 and s 80 make a poorly documented handover costly for both sides. Section 79 provides that where an agent or employee commits an offence the principal is equally liable, and where a body corporate is convicted, every director and every person involved in management may, in specified circumstances, commit the same offence. Section 80 makes sale prosecutions strict liability: intent need not be proved, and the no-intent plus all-reasonable-steps defence must be notified in writing to the prosecutor within 7 days of service of the summons or it is inadmissible. If the outgoing sponsor fails to mark its record Obsolete in time, the reg 8 correction duty continues for devices it no longer supplies; if the new sponsor misses its deadline, it breaches reg 6 and faces a reg 14 conviction fine not exceeding NZ$500. The duties run in parallel; neither is excused by the handover.

Insight 4: labelling and advertising names must switch in step. The changeover is not only a database action. Reg 12(4) of the Medicines Regulations 1984 requires devices to bear the manufacturer’s name or the name of the manufacturer’s distributor in New Zealand; once the distributor changes with the sponsor, the label must be updated in step. Reg 10 prohibits implying that database inclusion constitutes official endorsement, so changeover-period marketing must not imply approval because a WAND notification was completed.

4. Practical recommendations

• First determine whether a change of sponsor actually occurs. GRZAN first examines trade documents: does the new entity import or arrange the import itself? An entity that merely buys and resells from the original sponsor is not a sponsor and needs no new record.
• Schedule new record first, old record later. GRZAN advises the new sponsor to start its notification before first arrival, using the full 30 working days of reg 6, while the original sponsor sets the status to Obsolete only after confirming supply has stopped, avoiding a gap with no live record.
• Transfer the s 38 evidence capability with a written handover list. At minimum: risk classification rationale, GMDN code, UPI for Class III and AIMD, manufacturer information, the technical documentation package, and post-market adverse events with open corrective actions. GRZAN typically drafts this as a sponsor handover confirmation signed by both parties.
• Physically hand over the distribution records. Sponsors must keep distribution records so all affected users can be contacted in a recall or corrective action; if the historical records are not transferred, the incoming sponsor’s recall capability for products already sold is a blank.
• File administrative changes through the designated channels and keep proof. Sponsor detail changes go on the Sponsor Details Update Form, administrator changes on the WAND Administrator Details Update Form, to devices@health.govt.nz or Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6145. GRZAN advises keeping submission receipts and Medsafe confirmations as reg 9 evidence.

5. Verification checklist

• □ Confirmed the new entity imports or arranges the import itself (reg 3 sponsor)
• □ New sponsor completed the new record notification and reg 7 declaration within 30 working days
• □ Original sponsor will set its record status to Obsolete after stopping supply
• □ Signed a sponsor handover confirmation covering classification rationale, GMDN code, UPI and manufacturer information
• □ Technical documentation package transferred so the new sponsor can meet the 45-day s 38 duty
• □ Historical distribution records transferred so all previously supplied users can be contacted
• □ Reg 12(4) labelling name plan updates in step with the distributor change
• □ Administrative changes submitted via the Sponsor Details Update Form or WAND Administrator Details Update Form with receipts retained
• □ Marketing material contains no wording implying official endorsement (reg 10)

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