Amazon PHC Program - is it still available?
We are a manufacturer of class 1 professional use only medical devices (dental instruments) and we are seeking to begin selling direct on Amazon. It was our understanding that we need to be added to the AZ Business Professional Healthcare Program to be able to sell these devices to licensed medical providers only, however I have not heard from the PHC team since I submitted our onboarding form last October, and the account manager I have been working with suggested that we just list all our products on Amazon and wait for them to be tagged as unsafe for general use so we can provide the documents at that point. However, we would be providing documentation for ~500 different listings and be outside our FDA compliance by doing so.
This has led me to think that the PHC program may not be live or may not be accepting new applicants. We are not a reseller of these instruments, we manufacture and will be fulfilling them ourselves, and the account manager suggested that selling on Amazon 'may not be for you' which is not an acceptable response to us. Can anyone confirm if they have had a similar experience trying to sell these types of items on Amazon, or does anyone have any advice on how to stay in compliance with FDA and Amazon policy if all of our items need to be registered as professional use only?
Amazon PHC Program - is it still available?
We are a manufacturer of class 1 professional use only medical devices (dental instruments) and we are seeking to begin selling direct on Amazon. It was our understanding that we need to be added to the AZ Business Professional Healthcare Program to be able to sell these devices to licensed medical providers only, however I have not heard from the PHC team since I submitted our onboarding form last October, and the account manager I have been working with suggested that we just list all our products on Amazon and wait for them to be tagged as unsafe for general use so we can provide the documents at that point. However, we would be providing documentation for ~500 different listings and be outside our FDA compliance by doing so.
This has led me to think that the PHC program may not be live or may not be accepting new applicants. We are not a reseller of these instruments, we manufacture and will be fulfilling them ourselves, and the account manager suggested that selling on Amazon 'may not be for you' which is not an acceptable response to us. Can anyone confirm if they have had a similar experience trying to sell these types of items on Amazon, or does anyone have any advice on how to stay in compliance with FDA and Amazon policy if all of our items need to be registered as professional use only?
6 antwoorden
Seller_i6S8knzW6zU6Z
Hi @Seller_ndl7cZIabYf8b
According to the help pages, dental devices like dental burs are specifically listed as examples that require participation in the Professional Healthcare Program (PHC) (https://sellercentral.amazon.com/help/hub/reference/G200164650).
Given that you have ~500 Class 1 professional-use only medical devices, waiting to list and then handling compliance issues afterward could create significant complications. The PHC program (https://sellercentral.amazon.com/help/hub/reference/GFFRHXRJSRGPZ9UL) is the appropriate path forward to ensure FDA compliance from the start.
Since you're experiencing delays with your October onboarding submission, I'd suggest:
- Keep following up on your submission
- Share your case ID here - a forum moderator might be able to help escalate this
- Wait for PHC approval before listing the products
Kind regards, Michael
Glenn_Amazon
Hi there @Seller_ndl7cZIabYf8b,
As the Professional Health Care Program is part of the Amazon Business features, in general Seller Support is not able to assist. Do you have any information regarding your onboarding (like a Case ID or the body of the message) that I might be able to use to investigate deeper? Thank you for your understanding.
-Glenn
