Diagnostic Devices Authorized for Use Against Coronavirus (COVID-19)

How to Identify Authorized COVID-19 Medical Devices

In addition to existing medical device databases, there are lists of authorized COVID-19-related medical devices. These lists are a result of regulatory tools in place to expedite access to COVID-19 medical devices.

The following information explains what resources to check to determine if a medical device has been licensed or authorized in Canada.

Class I Devices (such as masks, respirators, eye protection, gowns and swabs)

Class I medical devices can be imported or sold according to one of 4 possible mechanisms:

• The manufacturer or importer holds a Medical Device Establishment Licence (MDEL)
• The device is included in the list of authorized medical devices other than testing devices
• The device is included in the list of medical devices for expanded use in relation to COVID-19
• The device is included in the list of medical devices for exceptional importation and sale