How classification works in New Zealand
Risk-based classification
New Zealand classifies medical devices based on their potential risk to patients and users. Higher-risk devices are subject to closer regulatory scrutiny and require stronger conformity evidence. Lower-risk devices have lighter requirements.
Classification is set out in Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003 — a set of 22 rules covering non-IVD devices. IVD classification follows separate rules.
Who classifies the device?
Medsafe does not classify devices. Classification is the responsibility of the manufacturer or sponsor, and must be justified in technical documentation. Medsafe does not offer pre-market classification rulings. If you are uncertain, consult the manufacturer or seek independent regulatory advice.
The classification hierarchy — non-IVDs
New Zealand uses five classes for non-IVD devices, in increasing order of risk:
| Class | Risk level | Examples |
|---|---|---|
| Class I | Lowest | Bandages, examination gloves, walking frames |
| Class IIa | Low-medium | Blood transfusion sets, ultrasound equipment, sutures |
| Class IIb | Medium-high | Ventilators, surgical lasers, bone screws |
| Class III | Highest | Heart valves, coronary stents, implantable contraceptives |
| AIMD | Specific high-risk | Pacemakers, cochlear implants, implantable defibrillators |
The classification hierarchy — IVDs
IVDs use a separate set of classes (lower-case numbers):
| Class | Risk level | Examples |
|---|---|---|
| Class 1 | Lowest | General laboratory instruments, specimen collection items |
| Class 2 | Low-medium | Blood glucose self-tests, pregnancy tests |
| Class 3 | Medium-high | Blood grouping systems, HIV screening tests |
| Class 4 | Highest | CJD screening, blood group confirmatory tests |
IVDs are exempt from mandatory WAND notification under Schedule 1 of the Regulations. They can be voluntarily notified, and many sponsors choose to do so for documentation purposes.
How the 22 rules work
The 22 classification rules in Schedule 2 are applied based on the device's:
- Intended purpose — what the manufacturer says the device is for
- Duration of contact — transient (≤60 min), short-term (≤30 days), long-term (>30 days)
- Degree of invasiveness — non-invasive, invasive, surgically invasive, implantable
- Anatomical location — body surface, body orifice, vascular, cardiac, central nervous system
- Energy use — whether the device emits or transfers energy, and of what type
If more than one rule applies, the highest resulting class takes precedence.
See The 22 Classification Rules for rule-by-rule guidance.
NZ vs EU and AU classification
New Zealand's rules are based on the original GHTF (Global Harmonization Task Force) framework — the same foundation used by the EU Medical Devices Directive and the Australian TGA prior to the EU MDR transition.
Because New Zealand has not adopted the EU MDR (2017/745) classification changes, some devices that moved from Class IIa to IIb (or from IIb to III) under the EU MDR may still carry their older, lower NZ classification. Always verify against Schedule 2 — never assume your EU MDR class is your NZ class.