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Welcome back to the Listing Lounge from your host Glenn! Hope your week is going great! I’m so glad to be able to provide you with support.

Selling Medical Devices on Amazon can be very complicated as there are many laws, regulations, and polices that impact you that don’t impact other Sellers.

While some products can be sold over the counter and some require professional use and prescription, all products that make Medical Claims or could be identified as a Medical Device require some form of documentation and appropriate labeling. Today I hope to prepare you so you know what you need to demonstrate your product is appropriate for Sale on Amazon.

The first step is to ensure you understand and review the Compliance Checklist below:

1. Ensure that you have appropriate sourcing for your products. Owners or operators of facilities that are involved in the production and distribution of medical devices intended for use in the U.S. must be registered with the FDA. For more information, go to Device Registration and Listing and Classify Your Medical Device.
2. Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. If your product is exempt from 510(k) clearance you will need to demonstrate that the product is exempt. Review the Class I and Class II Device Exemptions FDA Page for more information.
3. Medical devices must not have been the subject of any unresolved FDA enforcement such as FDA warning letters.

After ensuring your product is registered and has clearance and approval you will need to ensure you have proper labeling for your product. You can learn more on the FDA’s General Device Labeling Requirements.

Next is ensuring your Marketing Remains compliant with all laws and regulations.

The requirements below apply to all product marketing materials, including the product detail page, product packaging, and any instructional materials or package inserts included with the product.

• Medical devices must not make false or misleading statements.
• Medical devices must use the claims 'FDA cleared' or ‘FDA approved’ appropriately.
• Medical devices must not use the FDA logo.

Please note, if your product is one that requires a prescription it can ONLY be sold in the Professional Healthcare Program.

This should cover most of the documentation that you may require, however depending on your product it may have additional requirements. Be sure you have a great understanding of the policies, regulations, and laws that impact your product type.

Have you ever listed a Medical Device? What recommendations do you have for your fellow sellers to make sure that the process is smooth? Do you have any feedback on this category experience?

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 appeal that your product is not a Medical Device check out this Listings Lounge.

Good luck selling everyone and have a great day!

-Glenn