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January 16, 2026
Approximately 5 minutes
Advertising Requirements for Medical Devices in New Zealand
Advertising Requirements for Medical Devices in New Zealand
1. Legal Framework
Advertising of medical devices in New Zealand is regulated under the Medicines Act 1981, particularly sections 20, 22, 58, and 59, which control therapeutic claims and prohibit misleading advertising. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp The Act defines 'advertisement' broadly to include any statement or pictorial representation made in connection with the sale or promotion of a medical device. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
Therapeutic claims are restricted: only medical devices that are notified to the WAND database or meet exemption criteria can be advertised with therapeutic purposes to the public. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
2. Prohibited and Restricted Claims
It is an offence under the Medicines Act 1981 to make therapeutic claims for medical devices not listed in the WAND database, unless exempted. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
Prohibited claims include any representation that a device will prevent, alleviate, or cure any disease, ailment, defect, injury, or pain in humans, or affect the structure or function of the human body, unless the device is appropriately notified or exempted. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
Specific prohibitions apply to claims related to serious conditions (e.g., cancer, HIV, heart disease) or implying diagnosis/treatment without professional oversight. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
Advertisements must not be false, misleading, or deceptive, and must present balanced information including limitations, contraindications, and risks. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
3. WAND Notification Requirement for Advertising
To advertise a medical device to the public with therapeutic claims, the device must be notified to the Web Assisted Notification of Devices (WAND) database prior to advertising. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp Notification ensures the device complies with essential principles of safety and performance. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
Failure to notify before advertising therapeutic claims is a breach of the Medicines Act. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
4. Exemptions from Notification for Advertising
Certain low-risk or specific devices may be exempt from WAND notification but still subject to advertising controls. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp Exemptions do not automatically permit unrestricted therapeutic claims; advertisements remain regulated for accuracy and balance. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
5. Enforcement and Compliance
Medsafe monitors advertising compliance and may take action for breaches, including warnings, product seizures, or prosecution under the Medicines Act 1981. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
Sponsors and advertisers are responsible for ensuring all claims are substantiated and compliant. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
6. Additional Guidance
The page recommends referring to Medsafe's general advertising guidance for medicines and medical devices, and notes alignment with international standards for truthful and non-misleading promotion. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
This regulatory approach protects consumers from unsubstantiated or misleading claims while allowing appropriate promotion of compliant medical devices. https://www.medsafe.govt.nz/regulatory/DevicesNew/12Advertising.asp
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