Changes to Preclearance Procedures for Class II Medical Devices

Ad Standards is amending its procedures related to preclearance of Class II medical devices. Effective July 15, 2024, Ad Standards will be offering preclearance for this division of advertising in the form of advisory opinions. Approvals will no longer be issued.

In order to streamline and expedite our review process, going forward Ad Standards will require that submitters provide written attestation from the advertiser, signed by a senior medical, regulatory or compliance officer, confirming the exact indication(s) for use registered with Health Canada as part of the licence application for the advertised device(s). The applicable document must be submitted at the time of the initial submission for all Class II medical device reviews. Advertisers are encouraged to use the template provided as the basis for their attestation.

For consumer-directed advertising messages, Ad Standards’ advisory opinion will be based upon our analysts’ assessment of whether the ad is consistent with the provisions set out in the Guidelines for Consumer Advertising of Health Products, and the indication(s) for use provided in the advertiser’s attestation.

Note that in the case of non-promotional, information messages for Class II medical devices, Ad Standards will continue to evaluate compliance based on Health Canada’s Guidance on distinction between advertising and other activities for health products.

This change in procedure does not impact the validity of approvals previously issued by Ad Standards.

For any questions, please email clearance@adstandards.ca.