Medsafe
Medsafe — Medizinprodukte-Behörde New Zealand
New Zealand
Last reviewed 2026-06-21
Medsafe ist die nationale Regulierungsbehörde für die Medizinproduktaufsicht in New Zealand.
GERÄTEKLASSEN
Class I, IIa, IIb, III
ZULASSUNGSWEG
Medsafe registration
WICHTIGE REGULIERUNGSFUNKTIONEN
- ▸Geräteregistrierung
- ▸Marktüberwachung
- ▸Meldung unerwünschter Ereignisse
- ▸Import-/Exportkontrolle
OFFIZIELLE 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 überwacht Medsafe regulatorische Änderungen, Sicherheitswarnungen und Marktsignale in Echtzeit.
{abbr} KOSTENLOS ÜBERWACHEN →