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Medical Devices

Revised: 21 September 2015

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 products in New Zealand.

Definitions:
Explanation of a medical device
Definition of a sponsor
How to use the WAND database
See also:
Medical Device Legislation
Advertising of 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 New Zealand Medicines and Medical Devices Recall Code (PDF 468 KB, 49 pages)

Medical Device Legislation

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.

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