Listing A Medical Mask
We are the face mask manufacturer, and we have valid MDEL. When we tried to create a listing for the medical face mask level 1-3 which is classified as a Class 1 Medical Devices, the status of the product change to Detail Page Removed.
We provided our MDEL, lab test report, bilingual package (6 sides) and direction of use, but still, it is still showing that the product is Restricted.
How can we get approved?
Listing A Medical Mask
We are the face mask manufacturer, and we have valid MDEL. When we tried to create a listing for the medical face mask level 1-3 which is classified as a Class 1 Medical Devices, the status of the product change to Detail Page Removed.
We provided our MDEL, lab test report, bilingual package (6 sides) and direction of use, but still, it is still showing that the product is Restricted.
How can we get approved?
8 replies
Emet_Amazon
Hello @Seller_SrcTfzXaV2ouJ
Thank you for posting your concerns with our face mask policy.
We are the face mask manufacturer, and we have valid MDEL. When we tried to create a listing for the medical face mask level 1-3 which is classified as a Class 1 Medical Devices, the status of the product change to Detail Page Removed.
We provided our MDEL, lab test report, bilingual package (6 sides) and direction of use, but still, it is still showing that the product is Restricted.
Regarding face masks, this is the policy phrasing we typically use:
This product has been identified as a face mask, head covering, face shield, or related protection product that makes unapproved medical marketing claims regarding viruses, bacteria, or the flu. In Canada, if a product label includes anti-microbial claims, the products may be considered Class I medical devices. Medical Device Regulations requires that all claims must be supported by evidence and available for review upon request. Such claims include but are not limited to claims about a product’s anti-microbial, anti-viral or Bacterial Filtration Efficiency (BFE) features. In accordance with Canadian regulations, products that make medical marketing claims without meeting the requirements of the Medical Device Regulations may not be legally marketed in Canada without prior review and approval by Health Canada. Amazon policy prohibits the listing or sale of products that are not in compliance with Health Canada requirements. To be considered for reinstatement, please ensure any claims about the product’s use of capabilities are in compliance with Health Canada’s requirements.
Prior to being eligible for reactivation of these listings, you will be required to fully review the detail page and ensure all contributed information is not making any unapproved claims. If these claims are not removed or proof that they comply provided, they will not be eligible for reactivation.
You mentioned providing a MDEL which would show you are an approved to import, sell and or distribute any class of medical device, but does not show proof that the claims made on the listing comply with "our" policy.
Due to the limited information and visibility we have into your account, can you provide any related case, ASIN, or notification you received? When providing additional information in this space, please be sure to remove all personal information prior to posting.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
