Who needs to comply?
The Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003 place obligations on several parties in the device supply chain. Understanding who must do what prevents gaps in compliance.
Manufacturers
The manufacturer is the person or organisation that designs, produces, fabricates, assembles, processes, labels, or packages a device — or that adapts, refurbishes, or reprocesses it for supply.
Manufacturer obligations include:
- Ensuring the device is safe and performs as intended
- Holding technical documentation (design history, risk management records, clinical/performance evidence)
- Providing accurate labelling and instructions for use
- Cooperating with the NZ Sponsor on WAND notification and Medsafe requests
A manufacturer based outside New Zealand cannot directly notify WAND — they must appoint a Sponsor. However, manufacturers retain responsibility for the device's design and safety.
New Zealand Sponsors
The Sponsor is the NZ-based entity that takes legal responsibility for the device under the Medicines Act 1981. This is the most NZ-specific role in the system and the one with the most regulatory exposure.
Who can be a Sponsor:
- A New Zealand company (registered with the Companies Office)
- A New Zealand importer
- The manufacturer itself, if it has a legal presence in New Zealand
Core Sponsor obligations:
- Notify all relevant devices to WAND within 30 days of becoming Sponsor
- Update WAND within 10 days of any changes
- Hold evidence of device safety and performance
- Report adverse events to Medsafe
- Manage recalls and issue Field Safety Notices
- Maintain distribution records for traceability
- Ensure labelling and advertising compliance
- Respond to Medsafe information requests
See What is a Sponsor? for full detail.
Importers
An importer brings devices into New Zealand from overseas. The importer may also be the Sponsor — many NZ distributors act as Sponsor for the foreign manufacturers whose products they import. If the importer is not the Sponsor, they must still ensure:
- The device has been notified to WAND by the Sponsor before it is supplied
- Labelling is compliant with New Zealand requirements
- Distribution records are maintained
Distributors
A distributor supplies a device within New Zealand without importing it — for example, selling a device that another party has already imported and cleared through customs. Distributors must:
- Not supply devices that have not been notified to WAND (where notification is required)
- Ensure labelling is intact and accurate
- Cooperate with the Sponsor on recall and adverse event reporting
- Maintain records of supply to enable traceability
Healthcare providers
Healthcare providers who supply medical devices to patients (including hospitals, clinics, and individual practitioners) generally do so under normal supply chain obligations. However, healthcare providers who manufacture custom-made devices — including custom orthotics, prosthetics, or dental appliances — may have obligations as a manufacturer/Sponsor.
Hospitals that reprocess single-use devices may also have additional obligations.
Summary of obligations by role
| Role | WAND notification | Safety evidence | Adverse event reporting | Distribution records |
|---|---|---|---|---|
| Sponsor | ✅ Must notify | ✅ Must hold | ✅ Must report | ✅ Must maintain |
| Manufacturer (overseas) | Via Sponsor | ✅ Must hold | Must cooperate | ✅ Must maintain |
| Importer (not Sponsor) | Via Sponsor | Should have access | Must cooperate | ✅ Must maintain |
| Distributor | Via Sponsor | Not directly | Must cooperate | ✅ Must maintain |
| Healthcare provider / end user | Rarely | Not required | Should report | Depends on role |