Importing Medical Devices into New Zealand: Customs and Notification Requirements

1. Key takeaways

Regulatory information verified as of 29 October 2026. New Zealand operates no pre-arrival licence or approval for medical device imports issued by Medsafe. In this verification GRZAN found no official document in which the New Zealand Customs Service requires devices to be released against a Medsafe licence, approval or WAND notification receipt. The point must be stated precisely: no such requirement has been established and no official basis was found; it does not mean Customs has expressly declared one unnecessary — that assertion likewise has no official basis and must not be stated externally.

Medsafe’s importing guidance page (4Importing.asp) contains operational points rather than approval conditions, reducible to four steps: confirm whether the device is exempt; register as a WAND user first; the overseas manufacturer must first exist in WAND (for this verification Medsafe gives up to 10 working days, a service commitment rather than a statutory period); and once the device arrives, notification must be completed within 30 working days.

The real dividing line lies between import and sale. Goods can enter, but from the moment of sale duties take effect immediately: reg 12(4) of the Medicines Regulations 1984 (SR 1984/143) requires devices to bear the manufacturer’s name or the name of the manufacturer’s New Zealand distributor; s 38 of the Medicines Act 1981 requires devices to be safe for their intended purpose; Part 4 (from s 56) governs advertising; and reg 10 of the 2003 Regulations prohibits implied official endorsement. No gate at clearance, yet duties that start on landing: this contrast is the most widely misread feature of the system.

• No Medsafe import licence or approval exists for medical devices entering New Zealand.
• No official basis was found for Customs requiring Medsafe documents at clearance, and that absence must not be overstated.
• Medsafe’s four steps: exemption check, WAND user registration, manufacturer record first, notify within 30 working days of arrival.
• Sale-triggered duties (labelling, safety, advertising) must be ready before the goods land.
• s 37 reserves a Ministerial power to prohibit imports of specified devices for up to 1 year.

2. Legal basis

The instruments relevant to import and customs are set out below.

3. Expert insights

Insight 1: no Medsafe pre-approval does not mean no import restrictions at all. New Zealand genuinely has no device import licence, but s 37 of the Medicines Act 1981 reserves the Minister’s power, by notice, to prohibit absolutely or conditionally the import, manufacture, packaging, sale, possession, supply, use or administration of any specified kind of medical device for up to 1 year; the notice is secondary legislation published in the Gazette. This is a dormant power. Beyond it, product attributes can trigger other legislation: active electrical equipment falls under the Electricity Act 1992, wireless functions under the Radiocommunications Act 1989, irradiating apparatus under the Radiation Safety Act 2016, certain IVDs may engage the HSNO Act 1996, and contraceptive devices must meet Minister-approved standards. None is a Medsafe licence, but all are compliance items to confirm before import.

Insight 2: the overseas manufacturer entering WAND first is the only practical precondition. Medsafe’s guidance requires the overseas manufacturer to exist in WAND first, with verification of up to 10 working days. GRZAN flags this again: a service commitment, not a statutory review period. It is the genuine lead action: until the manufacturer record exists, the notification cannot be submitted. Reserve the window before first shipment rather than starting at the port.

Insight 3: notification happens after arrival, and that sequence is part of the system design. Reg 6 requires notification within 30 working days of becoming the sponsor, and Medsafe’s Regulatory requirements page explains that the period runs from the day the device first arrives in New Zealand. Arriving first and notifying within the period is itself the lawful path, not a precondition of import or sale. The reverse conclusion — that unnotified supply is unlawful — cannot be drawn: the 2003 Regulations contain no clause prohibiting sale of unnotified devices; enforceability lands on the deadline duty and reg 14 penalties.

Insight 4: three duties that apply on landing must be fully prepared in advance. The sale stage offers no grace period. Reg 12(4) requires devices to bear the manufacturer’s or New Zealand distributor’s name, settled at the production or labelling stage, since relabelling after arrival is expensive. Section 38 requires devices to be safe for their intended purpose, with evidence due within 45 days of the Director-General’s notice. Part 4 advertising rules apply immediately to any promotion aimed at the New Zealand public. All three must be finished before the goods arrive.

4. Practical recommendations

• Put manufacturer filing on the critical path of the first shipment. For a New Zealand first order, GRZAN treats overseas manufacturer filing in WAND as a lead milestone, working the start date backwards from the 10 working-day service commitment.
• Make an exemption determination before importing. Schedule 1 of the 2003 Regulations lists nine exemption scenarios, including devices already imported and held under Customs control pending export elsewhere, and devices imported by individuals solely for their own use. If an exemption applies, no notification is needed, but document the determination.
• Finalise the label before the factory gate. The reg 12(4) naming duty belongs to the sale stage but must be implemented at production; write the New Zealand labelling requirements into the first packaging specification to avoid relabelling after arrival.
• Run a linked arrival-to-notification ledger. Using the day the device first arrives in New Zealand as the start point, set the notification deadline at 30 working days and configure the reg 8 10 working-day correction trigger.
• Screen non-Medsafe import restrictions yourself. Electrical safety, radio spectrum, irradiating apparatus, hazardous substances and biological safety, and contraceptive device standards each have different regulators; GRZAN lists this layer as an other legislation checklist and clears every item before releasing the first shipment.

5. Verification checklist

• □ Confirmed no Medsafe pre-arrival licence exists for device imports and no official basis was found for Customs requiring Medsafe pre-approval
• □ External documents avoid phrases such as Customs has expressly declared approval unnecessary
• □ Determined whether the device falls within one of the nine exemption scenarios in Schedule 1, with the rationale documented
• □ Overseas manufacturer WAND filing started, worked back from the 10 working-day service commitment (service commitment)
• □ Registered as a WAND user with the notification owner designated
• □ Using first arrival in New Zealand as the start point, the 30 working-day notification deadline is locked
• □ Label meets the reg 12(4) naming requirement and is finalised at the production stage
• □ Screened applicability of the Electricity Act 1992, Radiocommunications Act 1989, Radiation Safety Act 2016, HSNO Act 1996 and CS&A Act 1977
• □ Prepared a safety evidence package capable of submission within 45 days under s 38

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