In the face of the COVID-19 pandemic the need for personal protective equipment has skyrocketed, leading businesses to source items like N95 face masks from outside of Canada.

It is important for importers to be aware that face masks of all types for use in a medical setting are considered class I medical devices by Health Canada and a Medical Device Establishment Licence is required to import and distribute class I medical devices.

If you do not have your Medical Device Establishment licence, Health Canada has an expedited process for obtaining your licence during the COVID-19 pandemic.

Face masks that are not represented or sold for medical use, such as those purchased at a hardware store, are not regulated by Health Canada.

Health Canada: Medical Device Establishment Licence (MDEL) application: instructions

Health Canada: FAQ: Medical device establishment licensing and fees

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