WAND System — Web Assisted Notification of Devices
The WAND (Web Assisted Notification of Devices) database has been New Zealand's primary mechanism for medical device market entry — sponsors notify Medsafe of their device, providing evidence of conformity assessment from a recognised body (TGA, EU Notified Body, Health Canada, or equivalent). Notification is not a product approval; Medsafe conducts post-market surveillance rather than pre-market review.
Under the incoming Therapeutic Products Act 2023, WAND will transition to a more structured scheme requiring formal conformity assessment evidence, with higher-risk devices subject to closer pre-market scrutiny. The exact shape of the replacement system is being developed through subordinate regulations.
🔖 Status: in-force (WAND); transitioning under TPA 2023
Sponsors currently relying on WAND notifications should continue to maintain their conformity assessment certificates and be prepared to provide updated evidence when the TPA commencement regulations require it. New market entrants should notify via WAND in the interim and track the TPA implementation timeline on the Medsafe website.
View official source (Medsafe WAND) ↗