Medical devices and accessories

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:

• Diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state or its symptoms;
• Restoring, modifying or correcting the structure or function of the body;
• Diagnosing pregnancy or preventing conception; or
• 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:

• The name and address of the manufacturer, including the street address, city, state and zip code;
• Directions for use;
• Expiration date, if applicable; and
• 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:

1. Making false or misleading statements.
2. Using misleading endorsements, including the claim “Health Canada Approved” or similar language.
3. Overstating effectiveness.
4. Promoting unauthorized (off-label) use.

For more information about illegal marketing, see this Health Canada guidance.

Examples of permitted listings

• 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:
  • Bandages
  • Medical support stockings
• 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:
  • Condoms
  • Digital thermometers

Examples of prohibited listings

• Products that require a prescription or a medical professional's supervision or direction for their use, such as:
  • Asthma Inhalers
  • Contact Lenses
  • Continuous, Variable, and Bilevel Positive Airway Pressure (CPAP, VPAP, BiPAP) devices and their accessories
  • Hypodermic needles and insulin injectors
  • Defibrillators
  • Infusion Sets
  • Insulin pumps
  • Light Therapy Devices
  • Nebulizers and their accessories, such as holding chambers
  • Oxygen concentrators, compressors, conservers, generators, condensers, and their accessories
  • Prescription eyewear
• Products that have not been licensed by Health Canada
• Products classified as Class III or IV medical devices, such as:
  • Cardiac Monitors
  • Pacemakers
  • Fetal dopplers and ultrasound machines
  • Pulse Oximeters
• Products that Health Canada has determined present an unreasonable risk of injury or illness, such as:
  • Ear candles
• Products that have been altered to change the product's performance, safety specifications, or indications of use
• Products that have passed their expiration or "use by" dates
• 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)
• 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
• Products that are adulterated
• Products that are misbranded, such as
  • Products that make unverified standard, effeciency, foreign equivalent, and/or medical claims
  • Unverified foreign equivalent products
• Products that contain mercury, such as thermometers and batteries
• Used and refurbished medical devices
• Products that are not sealed in the original manufacturer's packaging (open-box products)
• Products that have been the subject of a prior regulatory action, such as:
  • Health Canada advisories, warnings, or recalls
• Products that are not labelled or packaged as required by Health Canada regulations, including:
  • Products that do not meet bilingual labelling requirements and are not otherwise excepted from these requirements
• 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:
  • Matrix codes
  • Lot numbers
  • Serial numbers
• Products or instruments that are designed or intended for illicit drug use
• Products that are not intended for sale to the general public

Related Amazon help pages

• Restricted Products: Cosmetics & Skin/Hair Care
• Restricted Products: Drugs, Drug Paraphernalia & Dietary Supplements
• Listing Restrictions

Additional useful information

• Health Canada Medical Device Home Page
• Health Canada Drug and Medical Device Recall Listings
• Food and Drugs Act
• Medical Devices Regulations

Last Updated: 04/06/2021