Medsafe
Medsafe — New Zealand医疗器械监管机构
New Zealand
Last reviewed 2026-06-21
Medsafe是New Zealand负责医疗器械监管的国家监管机构，负责器械注册、市场监督和不良事件报告。
器械分类
Class I, IIa, IIb, III
审批路径
Medsafe registration
核心监管职能
- ▸器械注册
- ▸市场监督
- ▸不良事件报告
- ▸进出口管控
§ 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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