New Zealand uses a classification system based on risk to the human body. Increasing risk is assigned to Classes I ,Ila, IIb, III, and AIMD respectively. In New Zealand, market entry does require listing your product in MedSafe’s Web Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before it, there is documentation that proves device’s safety and effectiveness .Though manufacturers are free from obtaining pre-market approvals to enter the region, the proposed legislation changes and the willingness of New Zealand government to overhaul its existing Regulatory system might deviate market entrants with unclear Regulatory requirements. WAND listing includes the following information:
* Risk classification of the device
* Manufacturer’s contact information
* Global Medical Device Nomenclature (GMDN) Code
* Intended purpose of the device
Medsafe, the drug and medical device authority of New Zealand has taken steps towards this introducing a web-based online database however, only for the notification of devices in the market which means, there is no premarket assessment for all devices that get sold in the market. The notification process is comparatively very easy and the documentation that is prioritized by Medsafe is only the evidences of the device registration in other countries, like the FDA clearance, the CE certificate or the ARTG listing.