New Zealand Medical Device Regulation
Welcome to RAPath New Zealand — a plain-language reference for anyone navigating medical device regulation under Medsafe and the Medicines Act 1981.
Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is the regulatory authority for medical devices in New Zealand. It sits within the Ministry of Health.
What makes New Zealand unique
New Zealand's system is deliberately different from the EU, US, UK, or Australian frameworks in one fundamental way: there is no pre-market approval for most medical devices.
Instead, the regulatory model is built around three pillars:
- Notification — sponsors must enter device details in the WAND database before supply
- Sponsor accountability — a New Zealand-based Sponsor carries legal responsibility for every device on the market
- Post-market oversight — Medsafe monitors safety through adverse event reporting, recalls, and the ability to request technical documentation at any time
Who this site is for
- Foreign manufacturers entering the NZ market for the first time
- Sponsors and distributors managing their WAND obligations
- Regulatory affairs professionals keeping up with Medsafe requirements
- Healthcare providers who supply or procure devices
- Importers assessing their obligations under the Medicines Act 1981
Current legislative framework
| Instrument | Role |
|---|---|
| Medicines Act 1981 | Primary legislation governing medical devices |
| Medicines (Database of Medical Devices) Regulations 2003 | WAND obligations, classification rules (Schedule 2), exempt devices (Schedule 1) |
| Medicines Regulations 1984 | Labelling and advertising requirements |
| GHTF guidance | International reference framework used by Medsafe |
The Government is developing a Medical Products Bill to replace the Medicines Act 1981. The new Bill will introduce a modern, risk-proportionate framework including formal approval pathways for devices, SaMD regulation, and risk-based clinical trial approvals. A draft Bill was expected in late 2025. See Medical Products Bill Tracker for current status.
Quick start paths
New to NZ? → Start with What is a medical device? then Who needs to comply?
Ready to notify? → Go to WAND Overview then WAND Submission Process
Classifying your device? → See How classification works and The 22 Classification Rules
Need a Sponsor? → See Appointing a Sponsor
RAPath is a regulatory reference resource, not legal advice. Always verify requirements against the current legislation at legislation.govt.nz and Medsafe guidance at medsafe.govt.nz. Regulation changes — check the What's New section regularly.