Information for Medical Device Suppliers
Importing Medical Devices into New Zealand
All importers of medical devices - be they subsidiaries, agents, "private label" suppliers, parallel importers, or direct importers - have obligations that must be met when supplying product in New Zealand.
Definition of a medical device
New Zealand has its own legal definition of a medical device. Suppliers of medical devices should be familiar with this to ensure the products they supply are appropriately regulated. Medicines that have not been through the New Zealand medicines approval process that are being supplied as medical devices may breach the Medicines Act 1981.
Definition of a sponsor
The Sponsor is the New Zealand entity - importer, exporter or local manufacturer - that has the legal responsibility for a medical device supplied in New Zealand. This responsibility includes ensuring that medical devices are notified to the WAND database in accordance with the Regulations.
The WAND Database
The WAND database was established by the Medicines (Database of Medical Devices) Regulations 2003 to collect information about medical devices supplied in New Zealand. It is a mandatory requirement for importers, exporters and local manufacturers to notify their medical devices to the database. WAND is not an approval system for medical devices.
Multiple Importers of the same device
Where there is more than one importer of the same medical device each importer is required to notify that medical device to the WAND database. A WAND notification is specific to a particular combination of sponsor (importer) and device. It is not possible for one sponsor to "piggy-back" on another sponsor's notifications.
Records to be kept
Sponsors of medical devices are expected to maintain records of the supply of medical devices so that in the event of a recall or corrective action the importer is able to determine which customers have potentially been supplied with the affected product.
Sponsors should also have a written procedure describing how to conduct a recall action. Guidance on the recall procedure is contained in the "Uniform Recall Procedure for Medicines and Medical Devices".
Download a copy of the Uniform Recall Procedure
(Adobe PDF document 416 KB)
Advertising of Medical Devices
The Medicines Act and Regulations state what is, and is not, permitted when advertising medicines and medical devices. Devices that have, or claim to have, therapeutic properties must comply with the Medicines Act and Regulations.
The Medicines Act 1981 and its Regulations control the supply of medical devices in New Zealand. However some medical devices may be impacted by other legislation and regulations which must also be complied with before the devices may be legally supplied. It is the supplier's responsibility to ensure that their products comply with all applicable legislation.
Page last updated 10 May 2011