A local sponsor and a WAND notice
New Zealand has no pre-market approval for medical devices. Instead, the sponsor notifies Medsafe of each device in its WAND database within 30 working days of becoming its sponsor. The sponsor is the person in New Zealand who imports the device or arranges its import. Medsafe says overseas supply must be arranged through that local sponsor, and an organisation with no presence in New Zealand cannot be one. So the first question for any quote is who your sponsor will be.
Quotes, documents, and freight for healthcare buyers in more than 80 countries are our daily work at MediGear, a medical equipment distributor registered in England and Wales. For New Zealand, we look for verified makers whose units are built for 230 V with flat-pin plugs, and we send your sponsor the device details it needs. The points below are answered first, so the quote your biomedical engineers see is complete. Send your request through the buyers page;h no account is required.
Health New Zealand, Pharmac and private hospitals
We quote for Health New Zealand districts and for the private sector, including:
- Auckland City, Middlemore and North Shore hospitals
- Waikato Hospital in Hamilton and Wellington Hospital
- Christchurch and Dunedin hospitals in the South Island
- Private groups such as Southern Cross Healthcare, and orthopaedic teams
- Radiology, dental and veterinary practices with source licences
- Universities and research labs buying laboratory and scientific equipment
- Firms in medical import and distribution acting as WAND sponsors
Health New Zealand and Pharmac, both Crown agents, now share the buying of hospital devices. Health NZ generally leads laboratory equipment, theatre equipment and ward equipment. Buying of New Zealand diagnostic imaging equipment falls to Health NZ too, while Pharmac leads monitoring, anaesthesia, ventilation, infusion, dental, endoscopy and cardiology. Open tenders follow the Government Procurement Rules and appear on GETS, which is free to use. Health NZ's project pages said the New Dunedin Hospital's outpatient building was due to open in late 2026, with the inpatient building due in 2031. A private clinic that needs diagnostic instruments, or a regional hospital that needs one unit, only has to send the model. A university lab can request laboratory supplies and fixtures the same way.
Medsafe, WAND and the Medicines Act
Devices fall under the Medicines Act 1981. The Medicines (Database of Medical Devices) Regulations 2003 set up the WAND database, which is not an approval system. Medsafe runs it within the Ministry of Health, and a February 2026 Ministry briefing confirms that suppliers notify Medsafe only. Each notification belongs to one sponsor and one device, so a second importer of the same model notifies it again. The database is not public, so it cannot be searched to check a device.
Under the rules for selling medical devices, each one must bear the manufacturer's name, and we found no rule on the language of labels or instructions. A new Medical Products Bill is being drafted to replace the 1981 Act. We cannot act as a sponsor and give no regulatory advice, yet each quote spells out the certificates the unit holds.
New Zealand X-ray source licences, use licences and ORS C1.
The Radiation Safety Act 2016 makes it an offence to possess radiation sources without a valid source licence. An X-ray unit is one, and the regulator is the Office of Radiation Safety (ORS), part of the Ministry of Health. A source licence for an X-ray unit lasts up to three years, and adding a higher-risk source, such as CBC, to a plain radiography licence requires an approved variation first. Using a unit requires a use licence unless the user is a registered practitioner listed in the regulations, such as a radiologist, dentist, or medical imaging technologist.
ORS states that a seller must make sure whoever buys the unit holds a current and appropriate licence, so we ask for your licence before an X-ray unit ships. The unit must be registered when it arrives in New Zealand. Under the 2024 code for diagnostic and interventional radiology, a unit is calibrated at commissioning before clinical use. QA then follows periodically under a medical physics expert, with no fixed interval set. Installation and service technicians need their own licences.
230 V, flat-pin plugs and AS/NZS 3551
These details are confirmed with the manufacturer first:
- Voltage and pins. Mains is 230 V at 50 Hz, and plugs are flat-pin to AS/NZS 3112. A unit with that plug that is not designed for 230 V is electrically unsafe, so we confirm the build.
- Medical locations. Fittings and appliances in medical locations are deemed electrically safe if they comply with AS/NZS 3551 and related standards, so we ask how the unit is tested.
- Service visits. Installers and service engineers report in writing to the licence holder after their work, and spare parts and consumables can ship with the unit.
- Radiation tools as standard. The 2024 code asks suppliers to include radiation protection tools as standard rather than as optional extras, so we check what comes with the unit.
We put each open point to the manufacturer in writing, since your sponsor notifies the exact device and ORS registers the exact unit.
Import entries, the Trade Single Window and MPI
New Zealand Customs releases goods on the importer's electronic declaration, lodged through a customs broker, a freight forwarder, the Trade Single Window or EDI software. The entry must be completed within 20 days of arrival, and commercial importers above a low-value threshold also need a Customs client code. Each consignment is sent with:
- The commercial invoice and a packing list for the entry
- The bill of lading or air waybill for the broker
- Origin papers on request
- An HS code for every item on the entry
- The manufacturer's certificates and test reports
MPI's import health standard for wood packaging from all countries requires debarked wood with the ISPM 15 mark, dunnage included, and sets out what happens on arrival. Unmarked wood is handled as untreated, so it is treated, inspected, reshipped or destroyed, and the importer meets the expenses. We therefore ask makers for heat-treated, debarked and stamped crates.
Ports from Tauranga to Port Chalmers
- Model and sponsor. Send the model, quantity and site by RFQ form or email, and name your sponsor and licence holder.
- Quote and licence check. For catalogue items, the quote, usually ready within 48 hours, sets out certification, lead time, the port, any associated consumables and the papers your sponsor needs.
- Go-ahead. A signed-off quote, by email or letter, is our cue to order from the maker.
- North or South Island. Ships can berth at Tauranga, Auckland, Napier, Lyttelton or Port Chalmers, while air freight can be routed to Auckland or Christchurch airports.
Our delivery ends at the port or airport you nominate, where your broker lodges the import entry. The last leg is yours, and an X-ray machine in transit to you is registered to your location.
A single unit, a new hospital or refurbished medical equipment
A practice in Hamilton can ask for a single steriliser, and a clinic that needs sterilisation and decontamination equipment can ask the same way, since most catalogue lines are quoted one unit at a time. For a new facility, see clinic setup, and ward teams can browse Hospital Furniture and Fixtures. Pre-owned units from our refurbished range can be quoted too, as no New Zealand source we found restricts used or refurbished devices. The general rules still apply: your sponsor notifies the device, and an X-ray unit must be fit for purpose, meet IEC and ISO standards and be registered on arrival.
Disclaimer
The material here is general and written for New Zealand buyers. We make no offer to supply on it, and it cannot stand in for legal, regulatory or customs advice. What we quote depends on the maker's supply, and nothing is ordered until both sides agree in writing. Devices need a local sponsor and a WAND notice, and X-ray units need an ORS source licence and registration on arrival. Your sponsor and broker handle clearance and the regulatory side, since we cannot be a New Zealand sponsor or importer.
Who will be the WAND sponsor?
Supply from overseas must be arranged through a New Zealand sponsor, who notifies each device to WAND within 30 working days of becoming its sponsor. Name the model and the site, and our quote will show the certificates, the 230 V build and the route.
Frequently Asked Questions
Yes. A model number or a specification is enough, sent through the RFQ form on our buyers page or to connect@medigear.uk. Nobody needs an account, and we answer district hospitals, private groups, practices, medical equipment suppliers and New Zealand distributors by email.
No. New Zealand has no pre-market approval for devices, and WAND is not an approval system, so medical device distribution in New Zealand starts with a sponsor. The sponsor, the person in New Zealand who imports the device or arranges its import, notifies WAND within 30 working days of becoming its sponsor, and each importer notifies WAND separately.
No. Medsafe says organisations with no New Zealand presence cannot be sponsors, and overseas supply must be arranged through a local sponsor. Your hospital, a New Zealand distributor or another importer takes that role, and we send the device details it needs for the notification.
Yes, for X-ray and CT, so a hospital scanner that uses X-rays gets the same check. ORS says a seller must make sure the purchaser holds a current and appropriate licence, so we ask for your source licence before the unit ships. The unit is then registered on arrival, and higher-risk additions such as CBCT need an approved variation first.
The 2024 code for diagnostic and interventional radiology requires calibration at commissioning, before clinical use, and periodic QA under a medical physics expert. It sets no fixed numeric interval for radiography, fluoroscopy, CT or mammography equipment, so for medical imaging equipment we send the maker's own schedules with the quote.
Customs does not lodge entries itself. A customs broker, a freight forwarder, or the importer lodges it through the Trade Single Window or EDI software, and the entry must be completed within 20 days of arrival. We send the invoice, packing list, transport papers and HS codes.
It can. Most catalogue lines are quoted one unit at a time, and any minimum order the maker sets appears in our first reply—your sponsor still notifies WAND of the device, which we confirm before placing the order.
Usually the papers: an unclear sponsor, a missing WAND notice or a source licence that does not yet cover the unit. Wood packaging without the ISPM 15 mark is treated, reshipped or destroyed at the importer's expense. Our quote includes the lead time, port, and route.