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The Amazon Seller Forums Community Management Team welcomes you back to the Listings Lounge! It’s shocking its already mid-May! How time flies when you are making sales, right?
This topic is one that can be both technical and frustrating, what to do if your product is identified as a Medical Device. Now one might say “Glenn, there is no way that this product is a medical device. It’s obvious. Just look at it!” and it might seem simple but the classification of Medical Devices and Accessories can be quite complicated. Per Amazon’s Medical devices and accessories help page a Medical Device or accessory is defined as:
An instrument, apparatus, machine or related object used to diagnose, cure, treat, or prevent diseases in people or animals. Medical devices can also be used to change the structure or function of the body, such as stimulating hair growth.
This means even simple products like adhesive bandages are classified as Medical Devices!
In some instances, you may not have been prepared for your product being identified as a Medical Device or may disagree with Amazon’s determination. If you want to appeal the status of your product you will need to ensure the following:
- Ensure you know all the Laws, Regulations, and Policies that might apply to your type of product.
- Ensure that your product detail page, product packaging, and instructions do not include any Medical Claims. You can learn more about what these claims might look like on the Prohibited Product Claims help page. (Please note that if the claims are on the product packaging or instructions, the product will be ineligible to appeal it’s not a medical device)
In any appeal you will want to include photos of all sides of the product packaging, photos of each page of the instructions. Depending on the nature of the restriction you may need to provide additional details. I understand that this process can feel very difficult, however the purpose of these requirements is to product Buyers from possible harm. Thank you for your understanding.
Have you ever had a product identified as a Medical Device that you contested? Did you have success in appealing the classification of your product? What do you think might make this appeal process smoother? Provide your feedback and experiences here!
If you have specific questions on any difficulties you are encountering, we request you make a new thread with your most recent Seller Support Case. If you want to want to know more about how to sell Medical Devices check out this Listings Lounge.
Thanks for your time everyone and see you next time!
