Although advertising material for medical devices is no longer required to be precleared, it must be truthful, accurate and not misleading and must be in accordance with the indications of use approved in the corresponding device licence for Class II, III and IV devices. As Class I devices do not require a licence, advertising of these devices must be truthful and accurate based on corresponding evidence of effectiveness. Additional advertising requirements also exist for specific medical devices, including contraceptive devices.
The advertising of medical devices are subject to the applicable requirements of the Medical Devices Regulations and the Food and Drugs Act. There is no preclearance requirement for medical device advertising materials, which was originally a regulatory requirement under the Broadcasting Act. Under the Food and Drugs Act, no medical device can be advertised as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A and advertising cannot be false, misleading or deceptive. For Class II, III and IV devices, advertising is only permitted for licenced devices and claims are only permitted for the indications of use approved in the medical device licence. Advertising unlicensed Class II, III and IV devices is only permitted in catalogues when a suitable disclaimer is present indicating the devices advertised may not have been licensed in accordance with Canadian law. In addition, the advertising of Class I devices is also subject to the misleading or false advertising stipulations as well. Although these devices are not required to have a licence, evidence of effectiveness is required for this class of medical device and therefore any advertising claims regarding the efficacy of the product must be truthful. There are also special requirements under the Medical Device Regulations and the Food and Drugs Act for the advertising of specific medical devices, including contraceptive devices.
NHP Consulting will review your advertising material to ensure compliance with the applicable regulations and requirements for your specific class of medical device.