Medsafe
Medsafe — New Zealand Medical Device Regulatory Authority
New Zealand
Last reviewed 2026-06-21
Medsafe is the national regulatory authority responsible for medical device oversight in New Zealand. It manages device registration, market surveillance, and adverse event reporting within the Asia-Pacific regulatory framework.
DEVICE CLASSES
Class I, IIa, IIb, III
APPROVAL PATHWAY
Medsafe registration
KEY REGULATORY FUNCTIONS
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
OFFICIAL WEBSITE
https://www.medsafe.govt.nz →§ FAQ
What is Medsafe in New Zealand?
Medsafe is New Zealand's medicines and medical devices safety authority, operating within the Ministry of Health. It regulates medical devices through the WAND (Web Assisted Notification of Devices) system. New Zealand uses a risk-based classification system aligned with GHTF/IMDRF and accepts conformity assessment evidence from recognized international regulatory authorities.
How do I register medical devices in New Zealand?
Medical device registration in New Zealand requires submitting a notification through the WAND system. Sponsors must provide evidence of conformity assessment from a recognized regulatory authority (FDA, EU Notified Body, TGA, etc.) or from an IMDRF member audit report. New Zealand does not conduct its own full premarket reviews — it relies on reliance pathways.
MedFlux monitors Medsafe regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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