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.
Medsafe NZ at a Glance
| 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 |
Products We Commonly Support
- Medicines & APIs
- Medical devices
- In-vitro diagnostics
- Surgical consumables
How Global Approbation Handles Medsafe NZ
- Step 1. Appoint a New Zealand sponsor.
- Step 2. Classify the product as a medicine or medical device.
- Step 3. Medicines: prepare and submit the new-medicine application for Medsafe evaluation and consent.
- Step 4. Medical devices: the sponsor notifies the device on WAND with supporting evidence.
- Step 5. Maintain the approval or notification and report adverse events.
Documents Required
- GMP evidence for the manufacturing site
- Product dossier (medicines) or device evidence of conformity
- Overseas approvals (e.g. TGA, EU MDR, USFDA)
- Labels and data sheets
- Sponsor agreement
Medsafe NZ: Frequently Asked Questions
Is Medsafe NZ mandatory in New Zealand?
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.
Which products need Medsafe NZ?
Typical products include Medicines & APIs, Medical devices, In-vitro diagnostics and Surgical consumables. Coverage follows the regulator's current list and HS codes, so we confirm it for your exact product.
Does a foreign manufacturer need a local representative for Medsafe NZ?
Yes – NZ sponsor. Global Approbation coordinates with your importer or arranges a representative where needed.
How long does Medsafe NZ take and how long is it valid?
Typical timeline: Varies – ask us. Validity: Varies – ask us. Share your product details for a realistic plan and cost.
Does TGA approval cover New Zealand?
No. Australia and New Zealand regulate therapeutic goods separately, although an Australian approval is useful supporting evidence for Medsafe and WAND.
Regulations, standards and deadlines change. Scope, testing route and timelines are confirmed product by product after our applicability review. Global Approbation is a consultancy and does not itself issue certificates; approvals are granted by the relevant authority, accredited laboratory or certification body.