What is a New Zealand Sponsor?
The central concept
The New Zealand Sponsor is the entity that takes on legal responsibility for a medical device under the Medicines Act 1981. Every device supplied in New Zealand must have a Sponsor. This is the most NZ-specific concept in the regulatory framework and the one that most often catches foreign manufacturers off guard.
Who can be a Sponsor?
A Sponsor must:
- Be based in New Zealand — have a registered office or principal place of business in New Zealand
- Be a legal entity — a registered company, partnership, or individual with a NZ business presence
The following can all be Sponsors:
- A New Zealand importer who brings devices into the country
- A New Zealand distributor who sells the devices locally
- A local subsidiary of the overseas manufacturer
- The overseas manufacturer itself, if it has a registered legal entity in New Zealand
A foreign manufacturer cannot directly be a Sponsor without a NZ legal presence. If a manufacturer based overseas wants to control its own WAND entries, it must establish a NZ legal entity.
What the Sponsor is responsible for
The Sponsor is the legally responsible party for:
| Obligation | Detail |
|---|---|
| WAND notification | Notify within 30 days; update within 10 days of changes |
| Safety and performance | Ensuring the device meets the requirements of the Medicines Act |
| Technical documentation | Holding (or having access to) evidence of device safety |
| Labelling | Ensuring labels and IFU comply with GHTF guidance |
| Advertising | Ensuring promotional materials comply with the Medicines Regulations 1984 |
| Adverse event reporting | Reporting incidents to Medsafe within required timeframes |
| Recalls and FSCAs | Notifying Medsafe and issuing Field Safety Notices |
| Distribution records | Maintaining traceability records to support recall |
| Medsafe correspondence | Acting as Medsafe's primary contact for the device |
Sponsor vs manufacturer — who does what
The Sponsor and manufacturer share responsibility but in different ways:
| Responsibility | Manufacturer | Sponsor |
|---|---|---|
| Device design and manufacturing | ✅ Primary | — |
| Technical documentation | ✅ Generates it | ✅ Must hold/access it |
| WAND notification | Cannot do directly (unless NZ entity) | ✅ Must submit |
| Adverse event reporting to Medsafe | May need to cooperate | ✅ Must report |
| Labelling for NZ market | ✅ Produces | ✅ Approves for compliance |
| Recall execution | ✅ May coordinate globally | ✅ Must notify Medsafe and customers |
Liability exposure
The Sponsor carries significant legal exposure. Failing to notify WAND, failing to report adverse events, or supplying an unsafe device are all offences under the Medicines Act 1981. Sponsors should ensure they have:
- A formal written agreement with the manufacturer setting out documentation access and obligations
- Adequate professional indemnity or product liability insurance
- Competent regulatory staff or advisers familiar with NZ requirements
How NZ Sponsors compare to other markets
| Market | Term | Required to be local? | Formally registered? |
|---|---|---|---|
| New Zealand | Sponsor | Yes — NZ presence required | No — no separate registration, just WAND notification |
| Australia | Sponsor | Yes | No — ARTG listing |
| European Union | Authorised Representative | Yes — EU presence | No formal registration |
| United Kingdom | UKRP (UK Responsible Person) | Yes — UK presence | Yes — must register with MHRA |
| United States | US Agent (for foreign manufacturers) | No (must have US address) | No formal registration |