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§ ASIA-PACIFIC
Medsafe
Medsafe — New Zealand Medical Device Regulatory Authority
New Zealand
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 →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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