In order to commercialize your product in New Zealand’s small yet well-developed medical device market, you must meet requirements set up by the country’s medical device regulator, the Medicines and Medical Device Safety Authority (MedSafe).
Although pre-market approval of medical devices is not necessary 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. Once your device is listed in WAND, you must ensure that you have documentation available (such as certification from an EU Notified Body, Health Canada or US FDA), as MedSafe may request such information as proof of your device’s safety and effectiveness.
Emergo has registered hundreds of medical devices in New Zealand's WAND database. We can also assist you in preparing all necessary documents to address any information requests from MedSafe.
Please contact us for more information about medical device registration in New Zealand.