Importation and sale of medical devices for COVID-19 guidance document: Ensure that information is accessible

Information about a medical device must be available and in a form that is accessible to users, to ensure it is used safely. Specifically, an importer must:

• provide a detailed description of the medical conditions, purposes and uses for which the device is manufactured, sold or represented
• make available the performance specifications of the device if those specifications are necessary for proper use

Health Canada accepts that the level of detail provided for the product description and performance specification will vary depending on the type and complexity of the product. For example, the description and performance specifications of a surgical mask will be less detailed than for a ventilator.

Acceptable examples of information include:

• information bulletins or fact sheets in hard copy, which accompany the device
• information bulletins or fact sheets posted on the manufacturer’s website, which are referenced on the device’s label