Adding a Class 2 Medical Device
Hey y'all,
We're currently in the process of listing a class 2 medical device on Amazon. We know we'll have to send in our 510(k) approval to Amazon, but does anyone know when Amazon will ask for it? Can't really see a spot to upload it on the initial product creation interface.
Additionally, does anyone know if class 2 medical devices count as a dangerous goods and therefore have to be declared as "other" for the dangerous goods regulations question?
Thanks in advance!
Adding a Class 2 Medical Device
Hey y'all,
We're currently in the process of listing a class 2 medical device on Amazon. We know we'll have to send in our 510(k) approval to Amazon, but does anyone know when Amazon will ask for it? Can't really see a spot to upload it on the initial product creation interface.
Additionally, does anyone know if class 2 medical devices count as a dangerous goods and therefore have to be declared as "other" for the dangerous goods regulations question?
Thanks in advance!
1 reply
Glenn_Amazon
Hi there @Seller_pQCP04ghucx3i,
Thanks for reaching out with your questions on Medical Devices. In general if you need to provide Amazon will request it via Product Compliance Requests. You can learn more on the Submit compliance documents or appeal a documentation request help page.
Regarding Dangerous Goods, you can review your product to determine if it subject to the Dangerous Goods Policy via the Dangerous goods identification guide (hazmat).
It is recommended that you have all the relevant compliance and safety documentation for your any product you list.
If you have other questions on this issue, please feel free to reach out to me here. Thank you.
-Glenn
