Labelling and advertising
The regulatory frameworkβ
Labelling and advertising of medical devices in New Zealand is governed by:
- Medicines Act 1981 β general requirements
- Medicines Regulations 1984 β advertising rules
- GHTF/SG1/N43:2005 β the international standard Medsafe uses as its reference for labelling content
There is no equivalent to the EU MDR's detailed Annex I labelling requirements or the FDA's 21 CFR Part 801 β Medsafe's expectations are set by reference to GHTF guidance.
Minimum label content (GHTF/SG1/N43:2005)β
The following information should appear on device labels:
| Required element | Notes |
|---|---|
| Name or trade name of the device | |
| Name and address of the manufacturer | |
| Name and address of the NZ Sponsor | If different from manufacturer |
| Intended purpose | Or sufficient information to identify it |
| Lot/batch number | Preceded by "LOT" or the batch symbol |
| Manufacturing date | If relevant |
| Expiry date | For devices with a defined shelf life |
| Sterile indicator | If the device is supplied sterile |
| Single-use indicator | If applicable |
| Instructions for use (or reference to IFU) | |
| Storage conditions | If specific conditions are required |
Instructions for use (IFU)β
While no regulation explicitly mandates an IFU in New Zealand, Medsafe expects all medical devices to be supplied with appropriate instructions for use, consistent with GHTF/SG1/N43:2005. The IFU should cover:
- Intended use and patient population
- Contraindications and warnings
- Step-by-step instructions for use
- Maintenance and servicing instructions (where applicable)
- Disposal requirements
Electronic IFU (eIFU)β
Medsafe permits electronic IFU for devices where it is appropriate β for example, where the same IFU is used across multiple markets. The GHTF/SG1/N43:2005 guidance on eIFU applies.
No UDI requirementβ
New Zealand does not currently have a Unique Device Identification (UDI) requirement. There is no UDI database equivalent to the US GUDID or Australian AusUDID. Manufacturers who voluntarily apply UDI (for EU MDR, FDA, or TGA compliance) may carry that UDI labelling in the NZ market without issue β Medsafe does not prohibit it.
Advertising rules β Medicines Regulations 1984β
Advertising of medical devices in New Zealand is regulated under the Medicines Regulations 1984. Key rules include:
- Advertising must not be misleading or make unsubstantiated claims
- Claims must be consistent with the device's intended purpose as notified in WAND
- Prescription device advertising directed at consumers (rather than healthcare professionals) is restricted
- Advertising must not encourage inappropriate self-diagnosis or self-treatment
Medsafe monitors advertising and can require changes to claims that breach the Medicines Regulations.
Languageβ
All labelling and IFU for devices supplied in New Zealand must be in English (or include an English version). Unlike the EU, there is no requirement to supply in Te Reo MΔori or any other language β though some sponsors choose to do so for inclusivity.