Revised: 10 May 2011
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 products in New Zealand.
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.
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" (Adobe PDF document 416 KB, 15 pages).
The Medicines Act 1981 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 1981 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.
