What exporters to New Zealand need to know about Medsafe NZ: who needs it, products covered, the step-by-step process, documents and timelines.
| Authority | Medsafe (NZ Medicines & Medical Devices Safety Authority) |
|---|---|
| Countries | New Zealand |
| Mark | — |
| Requirement | Mandatory |
| Typical timeline | Varies – ask us |
| Validity | Varies – ask us |
| Local representative | Yes – NZ sponsor |
Medsafe regulates medicines and medical devices in New Zealand. Medicines need Medsafe consent before distribution, while medical devices must be notified on the WAND database by a New Zealand sponsor within 30 days of first supply. Existing approvals from reference regulators support the process.
Examples only – coverage is set by the regulator’s current product list and HS codes. We confirm it for your product free of charge.
Yes – Medicines need Medsafe consent before distribution in New Zealand, and medical devices must be notified on the WAND database by a New Zealand sponsor within 30 days of first supply.
Typical products include Medicines & APIs, Medical devices, In-vitro diagnostics and Surgical consumables. The official list changes over time, so we confirm coverage for your exact product and HS code in a free applicability check.
Yes – NZ sponsor. PCN coordinates with your importer or arranges a representative where needed.
Typical timeline: Varies – ask us. Validity: Varies – ask us. Share your product details and we will give you a realistic plan and cost.
No. Australia and New Zealand regulate therapeutic goods separately, although an Australian approval is useful supporting evidence for Medsafe and WAND.
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