Is ISO certificate needed for 501(k) exempt medical device?
Hello,
I am a new seller. Can anyone help us, if ISO certificate is needed for compliance if we will sell a 501(k) exempt medical device? Is is one of Amazon's requirement for compliance?
Thank you
Is ISO certificate needed for 501(k) exempt medical device?
Hello,
I am a new seller. Can anyone help us, if ISO certificate is needed for compliance if we will sell a 501(k) exempt medical device? Is is one of Amazon's requirement for compliance?
Thank you
2 yanıt
Seller_z3XfkorVSmnEY
If this item was being sold at a brick & mortar store in the US would the government require this certificate? (I'm thinking yes). Then yes, you need it to sell on Amazon. You need to follow all government rules regarding selling items even if Amazon does not ask you about the certifications the minute you list the item.
Rose_Amazon
Hi @Damsel,
Thanks for the post. I want to share with you the help page specific to medical devices, and particularly the following section:
"Registration, Clearance, and Approval
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.
Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. Note that most Class I devices are exempt from 510(k) clearance. For more information, go to 510(k) Clearances.
Medical devices must not have been the subject of any unresolved FDA enforcement such as FDA warning letters. For more information, go to Warning Letters."
Best regards,
Rose_Amazon
