What Is Required To Import Medical Masks Into Canada?
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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

How To Import Medical Supplies Into Canada
How To Import Medical Supplies Into The US
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About Author
Taryn Hannah
CCS, CTCS

Taryn Hannah has been in the trade industry since 2005. She began her carer with PCB in release operations, working with all modes and all release types. In 2010 Taryn moved to the Trade Compliance Group where after a year she became the Supervisor for regulatory compliance into Canada. With the experience she gained working in many areas of import service, she now assists the Operations Manager in special projects.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.