New Zealand in the global regulatory landscape
Medsafe's international participation
Medsafe participates in the International Medical Device Regulators Forum (IMDRF), the body that coordinates international regulatory harmonisation for medical devices. IMDRF guidance is a key reference for Medsafe in areas not explicitly covered by the Medicines Act 1981.
New Zealand's regulatory framework is most closely aligned with the GHTF (Global Harmonization Task Force) model — the predecessor to IMDRF — and through that, with the original EU Medical Devices Directive framework.
Regulatory comparison
| Feature | NZ (Medsafe) | AU (TGA) | EU (MDR) | US (FDA) | UK (MHRA) | CA (Health Canada) |
|---|---|---|---|---|---|---|
| Pre-market approval | No | Yes | Yes | Yes | Yes | Yes |
| Market entry mechanism | WAND notification | ARTG listing | CE marking | 510(k)/PMA/De Novo | UKCA/MHRA registration | Medical Device Licence |
| Formal conformity assessment | No | Yes | Yes (Notified Bodies) | Yes | Yes (Approved Bodies) | Yes |
| UDI requirement | No | Yes (staged) | Yes | Yes | Yes | Yes |
| PSUR required | No | For some | Yes | No (equivalent) | Yes | For some |
| IVD separate framework | No | Yes | Yes (IVDR) | Yes | Yes | Yes |
| Primary legislation | Medicines Act 1981 | Therapeutic Goods Act 1989 | EU MDR 2017/745 | FD&C Act | UK MDR 2002 | Medical Devices Regulations |
Multi-market submission strategy
For manufacturers targeting NZ as part of a broader APAC or global strategy:
NZ + AU — the most common pairing. The TTMRA provides a natural bridge. Use a single Sponsor for both markets where possible. Australian TGA evidence directly satisfies NZ conformity requirements.
NZ + EU + AU — CE certification and TGA listing together cover most global market entry evidence needs. NZ WAND notification is then administratively straightforward.
NZ standalone — possible but rare. Manufacturers entering NZ without other major market approvals need to be prepared to hold strong technical documentation, as there is no Notified Body or TGA process to generate conformity evidence.
Exporting from New Zealand
Devices manufactured in New Zealand and exported to other markets must meet the regulatory requirements of those destination markets — not just NZ's Medicines Act. A NZ manufacturer exporting to the EU must comply with EU MDR; exporting to Australia requires TGA registration; exporting to the US requires FDA clearance or approval.
For export-only devices not supplied in NZ, Cabinet has confirmed that the Medical Products Bill will not require NZ regulatory approval — consistent with Australia's approach for export-only goods.