Creating the Overseas Manufacturer Record in WAND

1. Key takeaways

Regulatory information verified as of 29 October 2026. An overseas manufacturer cannot open its own record in WAND (Web Assisted Notification of Devices). The manufacturer record is submitted by the New Zealand importer acting as sponsor through the Notify a New Manufacturer function, and is established after Medsafe verification. For that verification Medsafe gives a service commitment of up to 10 working days. GRZAN flags this explicitly: it is Medsafe’s service commitment, not a statutory time limit; the 2003 Regulations set no assessment deadline for manufacturer records.

The record must be created first because it is a prerequisite of device notification. A device record must hang under an existing manufacturer record; without one the sponsor cannot complete the notification, and the 30 working-day deadline in reg 6 is not suspended while verification runs. The stacking of these two periods is the most common scheduling trap for an overseas manufacturer entering New Zealand for the first time.

The information to be entered is prescribed by reg 5(1)(b) of the Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325): the manufacturer’s name, the address of the manufacturer’s (New Zealand or overseas) registered office or principal place of business, and a contact telephone number or email. No qualification documents or system certificates are required from overseas manufacturers.

One premise is widely misunderstood: neither the Medicines Act 1981 nor the 2003 Regulations defines manufacturer. Medsafe’s guidance reads the term by its ordinary meaning: a manufacturer includes entities engaged in assembly, production or processing, entities who represent themselves as the manufacturer, and entities who attach, or allow others to attach, their own brand or mark to the product. Own-brand labellers and brand holders both sit in the manufacturer position in New Zealand.

• The sponsor files via WAND’s Notify a New Manufacturer; Medsafe verification takes up to 10 working days as a service commitment, not a statutory deadline.
• Manufacturer records are prerequisites for device notification and do not pause the 30 working-day reg 6 clock.
• Reg 5(1)(b) requires name, registered office or principal place of business address, and telephone or email.
• New Zealand has no manufacturing licence or GMP audit for devices (GMP audits cover medicines only).
• No statutory definition of manufacturer: assemblers, self-declared makers and own-brand labellers all qualify.

2. Legal basis

The instruments relevant to manufacturer records are set out below.

3. Expert insights

Insight 1: the filing duty sits with the sponsor; the data quality sits with the manufacturer. The record is submitted by the sponsor in WAND, but its content comes entirely from the manufacturer. Medsafe verifies whether the record duplicates an existing one and whether the information is usable; it does not audit qualifications, because New Zealand has no manufacturing licence or GMP audit regime for devices. GRZAN’s fixed practice is a manufacturer information confirmation letter locking down, in one pass, the legal name including the entity suffix, registered office address, principal place of business address, telephone and email, consistent with other markets. The same document prevents inconsistent spellings when several importers file later.

Insight 2: who the manufacturer is, is an open question; own-brand labellers should think ahead. Because the regulations do not define manufacturer, Medsafe applies the ordinary meaning and expressly captures those who attach their own brand or mark. Two consequences: a local company private-labelling for New Zealand may be both sponsor and manufacturer; and, per Medsafe’s example, an entity buying assorted products and assembling them into first aid kits for sale is a manufacturer, because it attaches its own mark to the finished product. For overseas manufacturers the risk: if the New Zealand importer sells under its own brand, whoever is entered as manufacturer in WAND determines where labelling compliance lands. 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; naming the wrong manufacturer forces the labelling logic to change.

Insight 3: fold the 10-working-day verification window into the 30-working-day schedule. Reg 6 requires notification and the reg 7 declaration within 30 working days of becoming sponsor. Medsafe’s website elsewhere has a 30 calendar-day formulation inconsistent with its own 30 working days; GRZAN advises scheduling on the stricter reading (practical estimate). Operationally the two windows run in series: until the manufacturer record exists, the notification cannot be submitted. GRZAN’s scheduling practice moves the start of filing to before first shipment and reserves the full 10 working days of verification, rather than starting when goods reach port.

Insight 4: delays are almost always duplicate records and name inconsistencies. The most common problem Medsafe encounters is a manufacturer already existing in WAND that the sponsor failed to find, so a new record was submitted with a slightly different spelling, through abbreviations, legal suffixes or transliterated place names. Verification is prolonged, or duplicate entries accumulate and later block reg 5(3) consolidation by kind, which requires the same manufacturer. Another recurring delay: unclear address character — reg 5(1)(b)(ii) asks for the registered office or principal place of business, and a manufacturing site address or an email will cause the record to be returned.

4. Practical recommendations

• Make manufacturer filing the first project milestone. GRZAN requires the record to be submitted after contract signature and before first shipment, reserving the full 10 working-day Medsafe verification window.
• Lock manufacturer information in writing before WAND entry. GRZAN advises a manufacturer information confirmation letter fixing legal name, registered office address, principal place of business address, telephone and email verbatim, shared by all New Zealand importers.
• Search WAND for an existing manufacturer record before submitting. If one exists, reference it; do not create a new one. GRZAN has seen two subsidiaries of one group each file, leaving one factory with two database entries; reconciling later costs far more than searching first.
• Decide private-label and assembly scenarios early. Brand owners, private labellers and kit assemblers can all be manufacturers; GRZAN advises a written determination at project start, cross-checked against the reg 12(4) labelling name plan.
• Route manufacturer changes into the reg 8 correction process. After a name or address change, the sponsor must procure correction within 10 working days; GRZAN advises writing the manufacturer’s change-notification duty into the distribution agreement with deadlines and owners.

5. Verification checklist

• □ Searched WAND for an existing record of the manufacturer to avoid duplicate filing
• □ Sponsor submitted the record through WAND’s Notify a New Manufacturer function
• □ Submission covers the name, registered office or principal place of business address, and telephone or email required by reg 5(1)(b)
• □ Address entered is the registered office or principal place of business, not the manufacturing site
• □ Reserved up to 10 working days for Medsafe verification (service commitment, not a statutory deadline)
• □ Manufacturer record completion precedes the reg 6 30 working-day notification deadline
• □ Written determination of who the manufacturer is, for private-label or assembly scenarios
• □ Reg 12(4) labelling name plan cross-checked against the WAND manufacturer record
• □ Manufacturer change-notification duty written into the distribution agreement, matched to the reg 8 10 working-day correction

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