I am currently seeking help regarding the removal of our product (ASIN B09VDLGPWZ), which has been determined to be a Class II medical device.
This is an ice roller designed to reduce swelling and relaxation through cooling, and the item does not involve any medical function or therapeutic effect. However, the product was suddenly taken off the shelves and we were informed that we needed to submit a Medical Device License (MDL) or UPHN Medical Device Certification.
The notification reads as follows, “This product is identified as a Class II medical device and does not provide a valid Medical Device License (MDL) number and/or device identifier. Amazon policy prohibits the sale or distribution of Class II medical devices that are not licensed by Health Canada. If your product is licensed accordingly, please ensure that the product listing includes a valid Medical Device License (MDL) and Device ID (please use the Safety & Compliance tab of the Seller Platform), or authorization and Device ID for UPHN devices.”
In case number 17356382451, we have stated several times that our products are not medical supplies. We have also provided evidence such as six views of the product packaging, instruction manuals, and purchase receipts. The issue remains unresolved after we have submitted the relevant content multiple times.
Hello @Christine_Amazon @Ricardo_Amazon @JiAlex_Amazon. i noticed that you have assisted with similar cases before. Can you help me with this issue?
Thank you in advance.