Regulatory framework overview
Medsafe — the regulator
Medsafe (New Zealand Medicines and Medical Devices Safety Authority) is New Zealand's regulatory authority for medicines and medical devices. Medsafe sits within the Ministry of Health and is responsible for:
- Administering the Medicines Act 1981
- Operating the WAND database
- Market surveillance and safety monitoring
- Adverse event and recall management
- Providing regulatory guidance
Medsafe does not have a formal pre-market approval function for most medical devices — it relies on sponsor accountability and post-market controls to manage risk.
The three pillars of the NZ system
1. Notification (WAND)
Almost all medical devices supplied in New Zealand must be notified to the Web Assisted Notification of Devices (WAND) database before supply begins — within 30 calendar days of a sponsor taking responsibility for the device. Notification is not approval: Medsafe does not assess or clear a device before it enters the market. Instead, WAND creates a record that allows Medsafe to:
- Identify all devices on the NZ market
- Contact sponsors quickly in a safety event
- Monitor market entry patterns
2. Sponsor accountability
Every device on the NZ market must have a New Zealand Sponsor — an entity based in New Zealand with a registered business here. The Sponsor:
- Is legally responsible for the device under the Medicines Act 1981
- Holds (or can produce) technical evidence of safety and performance
- Maintains WAND entries
- Reports adverse events and manages recalls
- Is Medsafe's primary contact point
Foreign manufacturers without a NZ presence must appoint a Sponsor before supplying devices.
3. Post-market oversight
Medsafe monitors the market through:
- Adverse event reports from sponsors, healthcare providers, and patients
- WAND database analysis
- International regulatory signals (from TGA, FDA, EMA, MHRA etc.)
- Medsafe-initiated audits and information requests
- Recall coordination
How NZ compares to other markets
| Feature | New Zealand | Australia (TGA) | European Union |
|---|---|---|---|
| Pre-market approval required? | No — notification only | Yes (ARTG listing) | Yes (CE marking) |
| Pre-market assessment by regulator? | No | Yes | Via Notified Bodies |
| Market entry database | WAND | ARTG | EUDAMED |
| Key local representative | Sponsor | Sponsor | Authorised Representative |
| Conformity assessment routes | None — evidence must be held | Multiple formal routes | Formal conformity assessment |
| UDI requirements | None currently | Yes (staged rollout) | Yes |
| Primary legislation | Medicines Act 1981 | Therapeutic Goods Act 1989 | EU MDR 2017/745 |
The legislative backbone
| Instrument | Key content |
|---|---|
| Medicines Act 1981 | Defines medical devices; sponsor obligations; offences; Medsafe powers |
| Medicines (Database of Medical Devices) Regulations 2003 | WAND obligations; Schedule 1 (exempt devices); Schedule 2 (22 classification rules) |
| Medicines Regulations 1984 | Labelling and advertising requirements |
| Medicines (Classification of Medical Devices) Regulations | IVD classification provisions |
Upcoming reform
The current framework under the Medicines Act 1981 was designed in an era before modern medical technology. The Government is developing the Medical Products Bill to replace it. Key planned changes include:
- Formal pre-market approval pathways for devices
- Explicit regulation of Software as a Medical Device
- Risk-based clinical trial approvals
- An independent statutory officer (rather than Medsafe within the Ministry of Health)
- Continued role for Medsafe as the day-to-day regulator
See Medical Products Bill and the Bill Tracker for the latest.
Under the Trans-Tasman Mutual Recognition Arrangement (TTMRA), goods lawfully supplied in Australia can generally be supplied in New Zealand without additional regulatory requirements. This has practical implications for how sponsors may leverage Australian TGA registration when entering the NZ market. See TTMRA and Australia for detail.