How to Sell Medical Devices at Amazon without Your Products Getting Deactivated or Removed

December 21, 2021  

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.

More information here:

https://sellercentral.amazon.ca/help/hub/reference/G200164650




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