20Advertisements—medical devices

20 Advertisements—medical devices

General requirements (1) An advertisement about a medical device must contain: (a) the trade name of the device; and (b) an accurate description of the device; and (c) one or more accepted intended purposes for the device; and (d) either of the following statements, prominently displayed or communicated: ALWAYS FOLLOW THE DIRECTIONS FOR USE ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE Additional requirements for advertisements that facilitate directly the supply of medical devices not able to be physically inspected before supply (2) Where: (a) an advertisement facilitates directly the purchase or other supply of a medical device; and (b) the device is not able to be physically inspected by a consumer before the purchase or other supply;

Note: For paragraphs (a) and (b), an advertisement that facilitates directly the purchase or other supply of a medical device without prior physical inspection includes an advertisement that is published on a website, social media, or a software application, through which a transaction for the device may be conducted.

then the advertisement must also include:
(c) each ingredient of the device that is a substance included in a schedule to the current Poisons Standard, where relevant; and
(d) if one or more health warnings apply in relation to the device—either of the following, prominently displayed or communicated:
(i) a list of the health warnings; or
(ii) a link to the health warnings.

(3) For subparagraph (2)(d)(ii), a link to health warnings in relation to a medical device must provide a consumer with direct access to the warnings or a document containing those warnings. (4) In this section:

accepted intended purpose means:

(a) in relation to a medical device that is included in the Register—an intended purpose that is accepted in relation to the inclusion of the device; or
(b) in relation to a medical device that is not included in the Register and is not prescribed for the purposes of subsections 42DL(12) and 42DLB(9) of the Act—an intended purpose that is displayed on the label of the device, and otherwise communicated in the instructions for use for the device.

Note: Regulation 7 of the Regulations prescribes therapeutic goods for the purposes of the offence and civil penalty provisions in subsections 42DL(12) and 42DLB(9) of the Act, respectively. Medical devices prescribed in this regulation, and not included in the Register, must not be advertised to consumers. Medical devices that are not prescribed, and not included in the Register, may be advertised to consumers.

health warning, in relation to a medical device (or an ingredient contained in the device), means a warning, contra-indication, precaution or restriction, that is: (a) required under a relevant instrument to be included on the label, or in the instructions for use, of the device; and (b) reasonably necessary to inform a decision of a consumer to purchase the device.