Medsafe
Medsafe — New Zealand醫療器材監管機構
New Zealand
Last reviewed 2026-06-21
Medsafe是New Zealand負責醫療器材監管的國家監管機構，負責器材註冊、市場監督和不良事件報告。
器材分類
Class I, IIa, IIb, III
審批路徑
Medsafe registration
核心監管職能
- ▸器材註冊
- ▸市場監督
- ▸不良事件報告
- ▸進出口管控
§ 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.
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