On January 2, 2018, Ad Standards began reviewing and issuing approval numbers for ads for medical devices that comply with Guidelines for Consumer Advertising of Health Products released on December 13, 2017.
Under the new Guidelines, Ad Standards will preclear advertising directed to consumers for Class II to IV medical devices. These classes cover a vast range of goods from contact lenses and tampons to breast implants. Class I devices are the least invasive type of devices, and unlike the other classes do not require a license to be sold in Canada. Although there is no preclearance, manufacturers of Class I devices are nevertheless responsible for ensuring their advertisements do not contravene section 20 of the Food and Drugs Act which states that advertising must not be “false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quantity, character, value, composition, merit or safety”.
The new Guidelines provide a concise, streamlined, user-friendly framework to help manufacturers of medical devices comply with section 20. One of the main principles in the Guidelines is that advertising should be consistent with the terms of the market authorization (“TMA”) granted by Health Canada. The TMA sets out the claims that have been authorized by Health Canada, and although claims may be paraphrased, they cannot, either directly or indirectly, exceed the parameters of the TMA.
The Guidelines set out principles for comparative advertising of therapeutic claims. For example, the compared products must have an authorized common indication for use, must have clinical relevance in humans, be substantiated by conclusive and relevant data, and must not attack the compared product in an “unreasonable manner”.
The Guidelines also set out how to communicate the risks associated with devices. For example, in the case of devices such as dermal fillers, contact lenses and hearing aids, advertisements are required to state “This product may not be right for you” and “talk to your healthcare professional”. There are technical requirements for such disclosures set out for each medium.
By providing this preclearance service for devices, Ad Standards is filling a void that was anomalous given that preclearance has been in place for other regulated categories.