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:

• Government/Health Canada Approval: The previous guide limited claims to depicting the products DIN, DIN-HM or NPN on the label or advertisements; the latest guide advises of an update released by the ASC in 2013 to stakeholders on the ASC website, but not directly in the guide, permitting the claim “Product X is authorized for sale by Health Canada”. Importantly, such a statement would only be permitted for Class II, III and IV devices which undergo Health Canada review and receive a market authorization. While this is quite logical, makers of Class I devices must ensure not to use this statement in advertising, as this category is neither reviewed nor approved by Health Canada.

• Claims presented in the advertisement must be consistent with the terms of the product’s market authorization: While this may seem obvious, it presents an interesting question as to how to market and advertise Class I Medical Devices which do not have a market authorization or Class II medical devices that are licensed with a rather limited indication for use. As the guidance highlights (and as the ASC has confirmed at a technical session), claims can still be made for Class I and II medical devices provided they are truthful and not misleading and possess substantiation where appropriate. The Marketed Health Products Directorate (MHPD) also encourages collaboration with the Directorate to ascertain that the claims made are compliant for these types of medical devices.

• Risk Communication: This section is likely familiar to makers of NHPs and nonprescription drug products, as risk communication in advertisements has previously been required under Section 2.21 of the Health Canada Advertising Guidelines. However, for Medical Devices, this section would be a new requirement for both printed advertising (e.g. brochures) and TV and radio advertisements, as shown in the table below

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 info@dicentra.com.

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.