Medsafe
Medsafe — Autorité réglementaire des dispositifs médicaux New Zealand
New Zealand
Last reviewed 2026-06-21
Medsafe est l'autorité réglementaire nationale responsable de la surveillance des dispositifs médicaux en New Zealand.
CLASSES DE DISPOSITIFS
Class I, IIa, IIb, III
VOIE D'APPROBATION
Medsafe registration
FONCTIONS RÉGLEMENTAIRES CLÉS
- ▸Enregistrement des dispositifs
- ▸Surveillance du marché
- ▸Déclaration des événements indésirables
- ▸Contrôle import/export
SITE OFFICIEL
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 surveille les changements réglementaires, alertes de sécurité et signaux de marché de Medsafe en temps réel.
SURVEILLER {abbr} GRATUITEMENT →