Medical Device? electric toothbrush?
Our electric toothbrush products B096H95L3J B09XDZWTHK B09XF2Q1PW B09Q85ZD34 B09Q82NX6J have been marked as:This product has been identified as a Class II medical device. But our product is just a regular electric toothbrush. We have checked the relevant policies on medical devices.It is obvious that our product does not meet the policy requirements. Our product is an electric toothbrush used for cleaning teeth and cannot diagnose, treat, alleviate or prevent diseases, disorders, abnormal physical states or corresponding symptoms. Do we want to know if toothbrushes are considered medical devices in the Canadian market? If our product is not a medical product, can you help us restore the product page?
Medical Device? electric toothbrush?
Our electric toothbrush products B096H95L3J B09XDZWTHK B09XF2Q1PW B09Q85ZD34 B09Q82NX6J have been marked as:This product has been identified as a Class II medical device. But our product is just a regular electric toothbrush. We have checked the relevant policies on medical devices.It is obvious that our product does not meet the policy requirements. Our product is an electric toothbrush used for cleaning teeth and cannot diagnose, treat, alleviate or prevent diseases, disorders, abnormal physical states or corresponding symptoms. Do we want to know if toothbrushes are considered medical devices in the Canadian market? If our product is not a medical product, can you help us restore the product page?
2 replies
Seller_z3XfkorVSmnEY
We don't sell in this category, but I'd first suggest that you review government restrictions and policies regarding the sale of electric toothbrushes. Then provide that information to Amazon and make sure that the product page doesn't have anything that implies that it's a medical device.
Emet_Amazon
Hello @Seller_GzKx9w1KuVk6G,
Thank you for posting your concerns with a restricted product policy in Canada.
Looking over the ASINs provided, I do see these are being listed and sold as ultrasonic cleaners. As @Seller_z3XfkorVSmnEY suggested, have you reviewed local, state and federal policies along with Amazon policy? Per Canada Health:
Rule 9(1) classifies all active therapeutic medical devices intended to be used to administer or withdraw energy to or from the body, together with any dedicated software, as Class II. Examples of devices that are Class II by Rule 9(1) are:
- Air pressure tourniquet
- Powered traction unit
- Air-powered dental hand-piece
- Non-invasive bone-growth stimulator
- Air conduction hearing-aid
- Powered toothbrush
- Transcutaneous electrical nerve stimulator for pain relief
This quote is from the Canada Health website, although I cannot link the page in this space you can find this information publicly available. As mentioned this being a powered toothbrush they are classified as a class II device, which requires proper registration and a Medical Device Licence (MDL) number and/or device identifier. Without proper registration of the device, we cannot permit its sale in Canada.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
