Skip to main content

Related legislation

Medical devices in New Zealand may be subject to additional legislative requirements beyond the Medicines Act 1981, depending on the device type.

Medicines Regulations 1984​

The Medicines Regulations 1984 are made under the Medicines Act 1981 and contain detailed provisions on:

  • Labelling — specific requirements for particular product types
  • Advertising — what can and cannot be claimed in promotional materials for medical devices
  • Sale conditions — restrictions on how certain devices may be sold

The advertising provisions in particular are directly relevant to any marketing of medical devices in New Zealand.

Electricity Act 1992 — electrically powered devices​

All electrically powered medical devices supplied in New Zealand must comply with the Electricity (Safety) Regulations 2010 made under the Electricity Act 1992. These regulations are administered by WorkSafe New Zealand.

Key obligations:

  • Devices must meet New Zealand electrical safety standards
  • Installers and suppliers of prescribed electrical equipment must be licensed
  • Medsafe compliance does not substitute for electrical safety compliance

Hazardous Substances and New Organisms Act 1996 (HSNO)​

Medical devices that contain hazardous substances — for example, devices that include chemicals, batteries, or materials classified as hazardous — may need to comply with the HSNO Act, administered by the Environmental Protection Authority (EPA).

This may affect:

  • Sterilisation agents (ethylene oxide)
  • Battery-powered implantable devices
  • Devices containing mercury or other hazardous materials
  • Some diagnostic reagents

Contraception, Sterilisation and Abortion Act 1977​

Contraceptive devices — IUDs, diaphragms, contraceptive sheaths — require compliance with additional requirements under the Contraception, Sterilisation and Abortion Act 1977 in addition to the Medicines Act. These devices are generally classified as high-risk (Class IIb or III) under Schedule 2.

Health and Disability Commissioner Act 1994​

While not directly a device regulation statute, the Health and Disability Commissioner Act 1994 and the Code of Health and Disability Services Consumers' Rights create obligations for healthcare providers in how they use and inform patients about medical devices. Device suppliers may need to ensure their products enable providers to fulfil these obligations.

Human Tissue Act 2008​

Devices that incorporate human tissue must comply with the Human Tissue Act 2008, which governs the storage, use, and disposal of human tissue. This Act is administered by the Ministry of Health separately from Medsafe's device regulation function.