Need a Help with Selling a Medical Devices on Amazon
Hello. I want to sell an OTC Class II Medical Device on Amazon, i.e. Electronic Blood Pressure Monitor. I have my 2 brands enroll in Amazon, one of which is already on Health and Household Category (dental flossers, massage guns, senior walkers, walking canes etc.). My manufacturer has all the FDA documentation, certifications (510K, GUDID) needed.
I find it very confusing and opposite information, if I may sell Blood Pressure Monitors or not. Some sources state that for selling Medical Devices one needs to be enrolled in Amazon Professional Healthcare program, while other sources state that for Over/The/Counter Medical Devices there is no need for that and only having required paperwork and labelling is enough.
Can anyone please tell me based on their experience or is here any Amazon Admin who can guide me thru?
Thank you all in advance for your help!!
Need a Help with Selling a Medical Devices on Amazon
Hello. I want to sell an OTC Class II Medical Device on Amazon, i.e. Electronic Blood Pressure Monitor. I have my 2 brands enroll in Amazon, one of which is already on Health and Household Category (dental flossers, massage guns, senior walkers, walking canes etc.). My manufacturer has all the FDA documentation, certifications (510K, GUDID) needed.
I find it very confusing and opposite information, if I may sell Blood Pressure Monitors or not. Some sources state that for selling Medical Devices one needs to be enrolled in Amazon Professional Healthcare program, while other sources state that for Over/The/Counter Medical Devices there is no need for that and only having required paperwork and labelling is enough.
Can anyone please tell me based on their experience or is here any Amazon Admin who can guide me thru?
Thank you all in advance for your help!!
0 replies
Seller_i6S8knzW6zU6Z
Hi @Seller_E84hJmqL7Qtd3,
I just reviewed Amazon’s > Medical Devices and Accessories help page < to see what guidance they offer.
From what I understand, you don’t need to be in the Professional Healthcare Program (PHC) to sell over-the-counter (OTC) medical devices like blood pressure monitors. The help page states that only PHC sellers can offer prescription medical devices - so the restriction applies to Rx, not OTC.
I also noticed blood pressure monitors aren’t included in the “Examples of permitted listings for only sellers in the Professional Healthcare Program” section. This list is labeled as “examples,” not a final list, but in my view, it suggests these items are allowed outside that program.
In the Compliance Checklist section, you’ll find the requirements for listing Class II non-exempt devices:
- FDA facility registration
- FDA 510(k) clearance
- Product labeling in English with manufacturer details and complete usage directions
It sounds like you already have the necessary FDA documentation, which puts you in a strong position. Just make sure your product page and packaging meet all the labeling points explained in the “Labeling” section of the help page.
Just to be sure, here’s my personal reading of the policy. For complete certainty, consider reaching out to Seller Support with your specific product details and documents.
Hope this makes things a little clearer!
Best,
Michael
