In early January 2018, the Advertising Standards Canada (ASC), the non-profit industry group that provides guidance to industry and Health Canada on acceptable marketing claims, provided an update to the 2006 Consumer Advertising Guidelines for Marketed Health Products (for Nonprescription Drugs including Natural Health Products). These guidelines do not have the force of law, but have been prepared to assist marketers and advertisers in ensuring that advertising directed at consumers remains truthful and not misleading and within the terms of the products market authorization, where applicable. While the older guide published in 2006 applied to nonprescription drugs and natural health products (NHPs), the newly released version also provides guidance for medical devices and vaccines, although cosmetic and food products remain excluded from this guide
For companies that have launched nonprescription drugs and NHPs (products that have a market authorization), this guide will be very familiar, as it builds on the original guidance published in 2006, with a few notable updates regarding Sugar Free, Sodium/Salt Free claims, and Allergen labelling.
However, for medical device companies, this guide will offer a great deal of change in the type of statements that can be used in advertising and the requested levels of evidence. Sections in the guide that are of particular interest to Medical Device manufacturers are:
|Medical Device Advertisement||Required Text in Advertisement|
|Where label provides direction of use||Always read and follow the label|
|Where product use may not be appropriate for certain individuals of some risks have been identified||This product may not be right for you. Always read and follow the label.|
|Where product use may not be appropriate for certain individuals or some risks have been identified and use, installation, adjustment, etc. Must be done through a healthcare professional||This product may not be right for you. Talk to your health care professional|
|Where a safety advisory has been issued and label information has not yet been updated||This product may not be right for you. Always read and follow the label.
Talk to your health care professional and visit Companywebsite.com for new product safety information.
The updated guidance is of great value to marketers of medical device products, however, care is still required to ensure that your medical device is classified correctly and has the appropriate marketing authorization where required. Additionally claims made in advertising, particularly for Class I and II medical devices, require substantiation to ensure that statements are truthful and not misleading. dicentra is skilled in medical device classifications, submissions, scientific substantiations and advertising reviews. We are happy to assist you with all your medical device needs. We can be reached at 1-866-647-3279 or firstname.lastname@example.org.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries.