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What Is Required To Import Medical Masks Into Canada?

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
Cherie Storms
CCS , CTCS, CBSA Professional Designate

Cherie Storms is the Operations Manager with Pacific Customs Brokers, Canada with over 15 years in international trade operations and regulatory experience. Since she joined the company in 2007 she has become an Executive Board Member for the Canadian Customs Brokers Society, BC Region, and was invited to speak at the Women in Transportation Annual General Meeting in 2010 regarding her experience with running the international logistics efforts of the Vancouver 2010 Winter Olympics. Cherie is also a member of CSCB's National Commercial Operations and eManifest Committee. In September of 2018, Cherie became a member of the Board of Directors of the Canadian Society of Customs Brokers. Cherie has spoken at many seminars on the importance of trade compliance and is currently enrolled in the British Columbia Institute of Technology (BCIT) Business Management Program with the goal of becoming an international trade lawyer.

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.