All,

Since Amazon added the Safety & Compliance tab in approximately May/June of 2024, there has been a significant increase in the illegal sale of class II medical devices. When I say illegal, I mean sellers are selling a device that does not have approval from Health Canada to sell. To legally sell a medical device in Canada, the manufacturer has to prove the device is safe and effective which takes years of audits, a robust quality management system and extensive submission to Health Canada to receive a Medical Device License (MDL)

Amazon's normal process is to require a MDL # and Device Identifier # to be added to the safety & compliance tab for review. Sometimes they also require images of the 6 sides of the packaging in french and english as well as the instructions in french and english. Sometimes they request the actual Medical Device License document provided by Health Canada.

Bad Actor sellers are now stealing MDL #s and Device Identifier #s and contributing them to new listings when the device they are selling IS NOT the device that is approved under the MDL. Forging these documents is a federal crime. This deceives Amazon into allowing these illegal devices to be sold and the sellers break 2 federal crimes; forging federal documents and sale of an illegal, unapproved medical device.

I have a Customer Success Manager and she and her team are escalating this and writing a proposal to update Amazon processes to include the necessity of the seller to provide a link to the manufacturers website to prove its the same device. This is a potential long term, large-scale solution. In the meantime, when I report violations in the "report abuse" tab, nothing ever happens because the asins are not reviewed by a human and when they are run through the algorithm, it comes up as "approved MDL"

I currently have a list of 37 asins that are illegally selling medical devices on Amazon Canada. I created an excel spreadsheet that includes the links to the manufacturers website for the actual product that is approved under the forged Medical Device License as well as a detailed explanation of what these bad actors are doing. I have a case open with Amazon 17002206131 where I'm constantly escalating and pushing this further.

My question is: Has anyone had success reporting illegal devices and having Amazon respond by removing them? If so, can you help me understand how to do this? There must be a better way than the "report abuse" tab which I've had no success. These devices are dangerous and will eventually hurt and potentially kill people.

As a final frightening point: these 37 asins are only in 3 categories. I've reviewed a total of 14 medical device categories and found another 300 illegal medical devices. There are hundreds of medical device categories and potentially thousands of illegal medical devices doing exactly what these bad actors are doing. There are things like oxygen concentrators being sold that can act like literal explosives if they are faulty and these devices have never been audited or approval for quality. it's absolutely terrifying and I'm just looking for the right avenue to alert Amazon to this.

I can provide any documentation you could need to help with this. Thank you