Health Canada’s COVID -19 Medical Device Database Can Be Very Misleading

Health Canada’s COVID -19 Medical Device Database Can Be Very Misleading

November 26, 2020 By

If you are involved in the importation or distribution of Medical Devices related to the COVID crises in Canada, then no doubt you are aware of Health Canada’s online database that goes under the name “Authorized medical devices for uses related to COVID-19”. Unfortunately, this database, however well-intentioned, has created an unintended and misleading impression.

The title of this database seems to imply that any Medical Device listed therein is somehow uniquely blessed by Health Canada for use against COVID. This would include certain personal protective equipment, such as masks, or certain testing/diagnostic devices, such as IR thermometers. As a result, many retailers and some consumers are insisting that a device appears in this database before they are willing to carry or purchase the product.

Actually, the opposite is true. Those devices listed in this database are there because they got a special exemption from having to meet the normal regulatory pathway requirements. For instance, perhaps the device is not labelled properly, or perhaps it has expired, or perhaps did not go through the normal full Health Canada premarket assessment for safety and efficacy. These devices have only temporary authorizations that will expire when the COVID crisis ends.

In reality, there are many duly authorized products for use in relation to COVID. These products hold a valid Medical Device Licence (MDL) and/or are imported and distributed under a valid Medical Device Establishment Licence (MDEL). However, they are not listed in the online Medical Devices for Uses Related to COVID-19 database, giving the impression that they are somehow inferior or invalid when it comes to COVID.

This situation is prompting many manufacturers and importers to apply to get their devices listed in the online database, even though they are already fully authorized to sell. This is strictly for appearance purposes. It results in duplicated efforts and takes up both the applicant’s time and Health Canada’s time. During this critical period, I am sure both parties have more pressing things to do.

Health Canada really ought to have thought this through in advance when choosing to name their database. Impressions are very important in this industry in general, and in particular during a pandemic. Interestingly, this same situation was avoided on the hand-sanitizer/disinfectant side (which are classified as drugs or NHPs and not devices). In that case, Health Canada chose to list all such products in their “COVID” database, whether they were licenced through the regular pathway or were authorized under the special Interim Order.

This matter was brought before Health Canada. However, it is hard to get a regulatory body to see things from a marketing perspective. Until more voices are heard, or even a collective voice such as through a trade organization, things are not likely to change.

The key take-away message for retailers: If the device in question is a Class I medical device (such as masks, gowns, face shields) then you should ensure your supplier has an MDEL. If the device in question is a Class II or higher medical device (gloves, IR thermometers, test kits), you should ensure that the manufacturer has an MDL. If they do, those products can be legally sold for their intended purpose. If they don’t, then, and only then, should you consult the COVID database to see if they have an interim approval for sale. Apart from that, there is nothing enchanted about Health Canada’s COVID database.

If you require assistance with compliance regarding medical devices, or even with navigating the current COVID regulatory landscape in general, please contact dicentra. We would be happy to discuss how we may be of service.