Important: If you supply products for sale on Amazon, you must comply with all
federal, provincial/territorial, and local laws and Amazon policies applicable to those
products and product listings.
This help page covers medical devices and accessories. A medical device is an
instrument or apparatus that is manufactured, sold or represented for use in:
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Diagnosing, treating, mitigating or preventing a disease, disorder or
abnormal physical state or its symptoms;
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Restoring, modifying or correcting the structure or function of the
body;
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Diagnosing pregnancy or preventing conception; or
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Caring for a person during pregnancy, during birth, and after giving
birth.
Health Canada groups medical devices into four classes, with Class I representing the
lowest risk and Class IV representing the highest risk. You may not sell a Class III
or IV device on Amazon.ca With limited exceptions, you must have a Medical Device
Licence (MDL) or a Medical Device Establishment Licence (MDEL) issued by Health
Canada to import or sell Class II medical devices Health Canada maintains a Keyword Index to Assist Manufactures in Verifying
the Class of Medical Devices, which identifies the Class assigned to
certain devices.
Please use the checklist below to ensure that your product complies with the
requirements of Canadian law and can be sold on Amazon.ca.
Compliance Checklist for Medical Devices and Accessories
Licensing
With limited exceptions, you must have an MDL or an MDEL to import or sell Class II
medical devices. Health Canada maintains a searchable MDL database and MDEL database .
Additional guidance regarding MDL and MDEL licensing requirements is available on
Health Canada’s website, here and here.
Labelling
Medical devices must be labelled in French and English with all information required
by applicable Canadian law, including but not limited to:
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The name and address of the manufacturer, including the street address,
city, state and zip code;
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Directions for use;
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Expiration date, if applicable; and
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Special storage conditions, if applicable.
Additional guidance on medical device labelling is available on Health Canada’s
website, including here.
Marketing
Medical devices may not be illegally marketed. Examples of illegal marketing
include:
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Making false or misleading statements.
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Using misleading endorsements, including the claim “Health Canada Approved”
or similar language.
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Overstating effectiveness.
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Promoting unauthorized (off-label) use.
For more information about illegal marketing, see this Health Canada guidance.
Examples of permitted listings
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Products classified as Class I medical
devices that: (1) meet all prescribed safety and effectiveness requirements, (2)
do not require a prescription, (3) are not otherwise prohibited, and (4) are
appropriately described and labelled, such as:
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Bandages
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Medical support stockings
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Products classified as Class II medical
devices that: (1) are sold by the holder of an active MDL or MDEL issued by
Health Canada, (2) do not require a prescription, (3) are not otherwise
restricted, and (4) are appropriately described and labelled, such as:
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Condoms
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Digital thermometers
Examples of prohibited listings
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Products that require a prescription or
a medical professional's supervision or direction for their use, such as:
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Asthma Inhalers
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Contact Lenses
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Continuous, Variable, and
Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their
accessories
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Hypodermic needles and insulin
injectors
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Defibrillators
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Infusion Sets
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Insulin pumps
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Light Therapy Devices
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Nebulizers and their
accessories, such as holding chambers
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Oxygen concentrators,
compressors, conservers, generators, condensers, and their
accessories
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Prescription eyewear
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Products that have not been licensed by
Health Canada
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Products classified as Class III or IV
medical devices, such as:
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Cardiac Monitors
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Pacemakers
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Fetal dopplers and ultrasound
machines
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Pulse Oximeters
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Products that Health Canada has
determined present an unreasonable risk of injury or illness, such as:
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Products that have been altered to
change the product's performance, safety specifications, or indications of
use
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Products that have passed their
expiration or "use by" dates
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Laser pointers and related products
that have not been approved for sale on Amazon (to submit a request to sell
laser pointers and related products in any category, see Laser
Pointers and Related Products)
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Listings claiming that a product is
intended to be used for the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans, unless the claim is authorized by Health
Canada
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Products that are adulterated
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Products that are misbranded, such as
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Products that make unverified standard, effeciency, foreign equivalent,
and/or medical claims
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Unverified foreign equivalent products
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Products that contain mercury, such as
thermometers and batteries
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Used and refurbished medical
devices
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Products that are not sealed in the
original manufacturer's packaging (open-box products)
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Products that have been the subject of
a prior regulatory action, such as:
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Health Canada advisories,
warnings, or recalls
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Products that are not labelled or
packaged as required by Health Canada regulations, including:
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Products that do not meet
bilingual labelling requirements and are not otherwise excepted from
these requirements
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Products that have had their packaging
altered in such a way that removes or obscures any required label information
(e.g., product identity, net quantity, or dealer information) or identifying
codes placed on the packaging by the manufacturer or distributor, such as:
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Matrix codes
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Lot numbers
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Serial numbers
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Products or instruments that are
designed or intended for illicit drug use
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Products that are not intended for sale
to the general public
Related Amazon help pages
Additional useful information
Last Updated: 04/06/2021