Revised: 10 May 2011

Medical Devices

Advertising of Medical Devices

The Medicines Act and Regulations state what is, and is not, permitted when advertising medicines and medical devices. Devices that have, or are claimed to have, therapeutic properties must comply with the Medicines Act and Regulations.

Definition of advertising

Section 56 of the Medicines Act 1981 provides the key definitions relating to advertising of medical products. The definitions for advertisement and publish appear below.

Advertisement means any words, whether written, printed, or spoken, and any pictorial representation or design, used or appearing to be used to promote the sale of medicines or medical devices or the use of any method of treatment; and includes any trade circular, any label, and any advertisement in a trade journal

Publish means—

Note that (e) covers the advertising of medical devices via the internet.

Legislation

The Medicines Act 1981 and its associated Regulations all place controls on the advertising of medical devices. These controls are broadly outlined below. Note that these controls are additional to any other legislative or regulatory controls on general advertising.

Medicines Act 1981, Part 4 Medical Advertisements
Part 4 comprises Sections 56 through 62 inclusive and references Schedule 1 of the Act. The sections of the Act are;

• s56 - Interpretation
• s57 - Restrictions on advertisements
• s58 - Further restrictions on advertisements
• s59 - Advertisements to contain true name of advertiser
• s60 - Exemption for certain advertisements
• s61 - Misleading branding
• s62 - Regulations relating to advertising
• Schedule 1 - Specific classes of diseases and physiological conditions

Medicines Regulations 1984, Part 3 Advertisements
Part 3 comprises Regulations 7 through 11 inclusive. The Regulations relevant to medical devices are;

• Reg. 7 - Advertisements not to claim official approval
• Reg. 10 - Advertisements for medical devices
• Reg. 11 - Advertisements for medical professions

Medicines (Database of Medical Devices) Regulations 2003
Regulation 10 notes that a manufacturer or sponsor of a medical device may not claim that inclusion in the database is an endorsement of the safety or suitability for use of that product by the Director-General of Health or the Ministry of Health.

Note that sponsors must ensure all of its advertising complies with all relevant legislation including the Fair Trading Act 1986 and the Commerce Act 1986 in addition to the Medicines Act 1981.

Claiming a therapeutic purpose

Claiming a therapeutic purpose for a product defines it as a therapeutic product and subject to the requirements of the Medicines Act 1981 and its Regulations. Understanding how the claim of a therapeutic purpose may impact on the regulation of a product will help prevent potential breaches of the legislation. A claim might be overtly made or implied.

See also: Explanation of Therapeutic Claims

Pre-vetting services

The Association of New Zealand Advertisers provides a pre-vetting service for advertisers of therapeutic products. The Therapeutic Advertising Pre-vetting System (TAPS) will review advertising material (including websites) for compliance with the relevant codes and Regulations.

Alternatively advertisers may wish to use consultants with experience in therapeutic product advertising to ensure compliance with the legislation and regulations.