What is not a medical device?
Not every health-related product is a medical device. Understanding the exclusions saves time and ensures you pursue the correct regulatory pathway for your product.
Products that work by pharmacological or biological means
If a product's principal intended action is achieved through pharmacological, immunological, or metabolic means, it is a medicine under the Medicines Act 1981 — not a medical device. Examples include:
- Prescription drugs and over-the-counter medicines
- Vaccines and biologics
- Blood products
- Gene therapies (where the therapeutic action is biological)
Some products combine a device component with a medicinal substance — for example, a drug-eluting stent. These are classified based on their principal mode of action. Medsafe applies the same borderline product analysis used by GHTF. See Combination Products for detail.
Cosmetics
Products intended purely for cosmetic purposes — altering appearance, cleansing, perfuming — are regulated under the Cosmetics Products Group Standard by the Environmental Protection Authority (EPA), not Medsafe. However, if a cosmetic product also claims a medical purpose (e.g., sunscreen with SPF claims that go beyond cosmetic protection), classification becomes more complex.
General wellness and lifestyle software
Software that tracks general fitness, provides generic health information, or is intended for wellness rather than medical purposes is generally not a medical device. The line between wellness software and Software as a Medical Device (SaMD) can be blurry. See SaMD and Digital Health for Medsafe's current approach.
Food and nutritional products
Foods, dietary supplements, and nutritional products are regulated by Food Standards Australia New Zealand (FSANZ) under the Food Act 2014. They are not medical devices, even if they have health benefits.
Hazardous substances
Substances hazardous to health or the environment are regulated under the Hazardous Substances and New Organisms Act 1996 (HSNO Act) by the EPA. Some medical devices that contain hazardous chemicals may need to comply with HSNO in addition to the Medicines Act obligations.
Human tissue for transplantation
Human tissue used for transplantation is governed by the Human Tissue Act 2008, not the Medicines Act. Devices incorporating human tissue, however, may still require notification depending on the device component's function.
Electrical safety and pressure equipment
While electrically powered medical devices must comply with the Electricity Act 1992 and WorkSafe requirements (Electricity (Safety) Regulations 2010), those requirements exist in addition to the Medicines Act — not as a replacement. An electrical product used purely for safety (e.g., a circuit breaker) is not a medical device.
Summary table
| Product type | Regulator | Framework |
|---|---|---|
| Medicines, vaccines, biologics | Medsafe | Medicines Act 1981 |
| Cosmetics | EPA | Cosmetics Products Group Standard |
| Foods and dietary supplements | FSANZ | Food Act 2014 |
| General wellness software | None specific | Not regulated as a device |
| Human tissue for transplant | Ministry of Health | Human Tissue Act 2008 |
| Hazardous substances | EPA | HSNO Act 1996 |
| Electrical equipment (general) | WorkSafe NZ | Electricity (Safety) Regulations 2010 |
Use Medsafe's categorisation service. Submit a product description, labelling, intended use statement, and promotional materials to devices@health.govt.nz for an advisory opinion before investing in WAND notification or technical documentation.