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This article applies to selling in: Canada

COVID-19 Supplies

This page covers product sold on the COVID-19 Supplies storefront. For more information on COVID-19 Supplies and how you can request approval to sell these products, visit: http://www.amazon.ca/COVID-19-Supplies.

COVID-19 Supplies is limited to pre-approved sellers. If you are approved to sell in COVID-19 Supplies, you may only sell the specific ASINs for which you have been approved to sell. If you would like to sell additional products in COVID-19 Supplies, or add an offer to an ASIN that is already part of COVID-19 Supplies, you must obtain prior approval.

These products are being made available exclusively to the 10 sectors identified by the Canadian government, including hospitals, government organizations, and others on the front lines of COVID-19. As such, it is critical that all product information is accurate. In addition to our Restricted Products policies, these products must comply with the guidelines below, unless you have received an express exemption from Amazon.

General guidance

Medical devices must meet the applicable requirements found under the Medical devices and accessories policy, including:

  1. Medical devices must not make false, misleading, or unsubstantiated statements. Misleading statements include any claims that the product protects against COVID-19, the virus, or any other acute infectious respiratory syndrome (with the only exception of specific sanitizers mentioned below).
  2. A product may not claim to meet any safety standard or level of effectiveness unless it holds a certification for that safety standard or level of effectiveness.
  3. A product may not claim to be "approved by Health Canada".
  4. In general, products must meet the applicable Specifications for COVID-19 Products identified by the Canadian government.

Masks and respirators

N95 masks

  1. Health Canada accepts NIOSH certification as an appropriate quality standard for N95 masks used by health care providers.
  2. N95 masks must be listed on NIOSH’s list of approved respirators and may include "NIOSH Approved" or "NIOSH Certified" on the detail page.
  3. N95 masks cannot make any "medical" or "surgical" claims on the detail page or product packaging, unless they separately meet the requirements listed below for surgical masks.

Equivalents of N95 masks (for example, KN95)

  1. In addition to NIOSH certification, Canada accepts the following equivalent standards:
    1. KN95 (GB2626-2006)
    2. CE FFP2 (EN149-2001)
    3. P2 (AS/NZ 1716:2012)
    4. Korea First Class (KMOEL – 2017-64)
    5. DS (Japan JMHLW-Notification 214, 2018)
  2. KN95 masks and other international equivalents cannot make any "medical" or "surgical" claims on the detail page or product packaging unless they separately meet the requirements listed below. However, they should include the manufacturer's name on the detail page.
  3. KN95 masks and other international equivalents cannot claim that the product is approved or endorsed by Health Canada or the Government of Canada, although they can claim to be a Class I Medical Device.

Surgical masks

  1. Any mask claiming to be a "medical" or "surgical" mask must certified under ASTM F2100 or EN 14683 standards, with a corresponding approval number.
  2. Surgical masks may describe the applicable ASTM standard, but only if the claim has been substantiated.

Other masks (face masks, dust masks)


  1. These are general purpose face masks that don’t meet the standards of other masks described above.
  2. These masks may not make any claims regarding medical or surgical use on the detail page or product packaging.

Disposable gloves


  1. Examination, medical, or surgical gloves: Any gloves making a medical claim (for example, "appropriate for medical, hospital, surgical use") must be certified to an appropriate quality standard and hold a medical device licence number from Health Canada.
  2. Other disposable gloves: may be sold, but they cannot make any claims related to medical use (for example, examination, surgical, patient, etc.) on the detail page or product packaging.

Gowns, scrubs, aprons, and shoe covers


  1. Surgical gowns, isolation gowns, and scrubs: Any gowns or scrubs that make medical claims or have symbols suggesting a medical use must hold a safety certification recognized by Health Canada.
  2. Other gowns, aprons, and shoe covers: If the product does not make any medical claims or have any associated imagery suggesting a medical use, it is not a medical device.

Face shields and protective goggles

If the face shields or goggles make any medical claim, then they must be manufactured by an entity that holds a Medical Device Establishment Licence and meet the specification identified by Health Canada in its guidance on Eye Protection for Hospital Use. Other face shields and goggles may be sold, provided that they don’t make any medical claims on the detail page or product packaging, and there is no associated imagery suggesting a medical use.

Thermometers


  1. Digital thermometers, including infrared: Products that make medical claims must hold a Medical Device Licence from Health Canada and meet the specifications identified in the Specifications for COVID-19 Products.
  2. Non-digital thermometers: Products that make medical claims must be manufactured by an entity that holds a Medical Device Establishment Licence.

Disinfectants


  1. Products must have a valid Drug Identification Number or Natural Health Product Number issued by Health Canada.
  2. If the product makes a claim about killing coronavirus, it must be listed in Health Canada’s Disinfectants for use against SARS-CoV-2 (COVID-19) List.

Hand sanitizers


  1. All products must have a valid Drug Identification Number or Natural Health Product Number issued by Health Canada.
  2. If the product claims to meet Health Canada’s requirements for safety, effectiveness, and quality, it must be listed on Health Canada’s List of Approved Hand Sanitizers.

Last updated May 11, 2020

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