New Zealand

Medsafe WAND Registration

The Medicines and Medical Devices Safety Authority (Medsafe) regulates the medical device market in New Zealand. Unlike pre-market approval systems, New Zealand utilizes a post-market notification system called WAND. Foreign manufacturers must appoint a local New Zealand Sponsor to complete this notification and maintain compliance.

Medsafe Regulatory Framework

New Zealand operates a unique regulatory framework. Rather than requiring extensive pre-market review by Medsafe, the system mandates that all medical devices must be notified to the Web Assisted Notification of Devices (WAND) database within 30 days of the device being placed on the New Zealand market.

This streamlined approach heavily relies on the manufacturer already holding robust regulatory approvals from recognized jurisdictions (such as CE Marking from Europe or TGA approval from Australia). The responsibility of ensuring the device meets all safety and performance standards falls squarely on the New Zealand Sponsor.

New Zealand Sponsor Requirement

Foreign manufacturers MUST appoint a local New Zealand Sponsor. The Sponsor must be a resident or a registered company in New Zealand. They are legally responsible for entering device details into the WAND database, holding technical documentation, and managing post-market surveillance and adverse event reporting.

Ready to launch in New Zealand?

Speak to our Medsafe Regulatory Experts

Book a Consultation