Wrongly marked as Medical device
Hello everyone!
We are a company providing genetic profiling through buccal swabs and saliva spit tubes, giving information on nutrition and workout based on genetic profiles. We have been trying to sell our kit on Amazon but we have been wrongly marked as a medical device, leading to Amazon prompting us to provide ISO certifications and/or a declaration of conformity. We have been confirmed by an independent advisor dealing with other companies who manufacture our supplies that we are definitely 100% not selling a medical device, but a lifestyle product.
It seems impossible to get into contact with anyone who could help us lift the block of making changes to our products and seller central does not get back to our inquiries. Anyone experience in similar situations or any idea how to finally get someone to talk to us?
Thanks in advance.
0 replies
Seller_hC0hNVDuILaKO
Are you making any [medical] claims about what your product can achieve for people?
Seller_EJIX7rqDNQJi2
Once Amazon flagged your product as a Medical Device, there is nothing you can do. You won’t be allowed to sell it unless you obtain an approval for the category.
Also, I would advise you not to try circumvent the restriction by creating a new listing. You should work on obtaining the approval.
