Urgent Moderator Help – Health Canada–Licensed Class II Medical Device ASIN B0F8PJHCP5 Still Not Reinstated (Multiple Case IDs)
Dear Amazon Moderator,
I am urgently requesting your help regarding ASIN B0F8PJHCP5, a Class II medical device licensed by Health Canada, which remains deactivated despite full compliance and multiple case submissions.
I am both the official Canadian Medical Device Licence holder and the Health Canada–listed manufacturer for this device.
Despite submitting everything Amazon has requested, including:
-Bilingual images of all six sides of my Health Canada–licensed packaging
-English and French Instructions for Use approved by Health Canada and physically included in the box
-A copy of my official Health Canada Medical Device Licence
-A screenshot of the active MDALL listing
-An email from the Manager of Device Licensing Services at Health Canada, confirming my licence is active and valid
I continue to receive vague, copy-paste responses from the Medical Device Compliance Team stating that the “product detail page contains insufficient information.” I have already updated the product detail page, added the model number, and uploaded all required images.
This is a Health Canada–licensed, fully compliant device. I am the Health Canada authorized manufacturer and licence holder.
Case IDs:
17965875871
17963842341
17925102551
17924709881
17898662561
I respectfully ask that a moderator escalate this to a human reviewer who can properly assess the documentation and reinstate this compliant listing.
Sincerely,
Dr. Jason Wilson
Urgent Moderator Help – Health Canada–Licensed Class II Medical Device ASIN B0F8PJHCP5 Still Not Reinstated (Multiple Case IDs)
Dear Amazon Moderator,
I am urgently requesting your help regarding ASIN B0F8PJHCP5, a Class II medical device licensed by Health Canada, which remains deactivated despite full compliance and multiple case submissions.
I am both the official Canadian Medical Device Licence holder and the Health Canada–listed manufacturer for this device.
Despite submitting everything Amazon has requested, including:
-Bilingual images of all six sides of my Health Canada–licensed packaging
-English and French Instructions for Use approved by Health Canada and physically included in the box
-A copy of my official Health Canada Medical Device Licence
-A screenshot of the active MDALL listing
-An email from the Manager of Device Licensing Services at Health Canada, confirming my licence is active and valid
I continue to receive vague, copy-paste responses from the Medical Device Compliance Team stating that the “product detail page contains insufficient information.” I have already updated the product detail page, added the model number, and uploaded all required images.
This is a Health Canada–licensed, fully compliant device. I am the Health Canada authorized manufacturer and licence holder.
Case IDs:
17965875871
17963842341
17925102551
17924709881
17898662561
I respectfully ask that a moderator escalate this to a human reviewer who can properly assess the documentation and reinstate this compliant listing.
Sincerely,
Dr. Jason Wilson
0 replies
Emet_Amazon
Hello @Seller_Q9uZPEn48B6ue,
Thank you for posting your concerns with your listing being removed.
I am urgently requesting your help regarding ASIN B0F8PJHCP5, a Class II medical device licensed by Health Canada, which remains deactivated despite full compliance and multiple case submissions.
I am both the official Canadian Medical Device Licence holder and the Health Canada–listed manufacturer for this device.
Despite submitting everything Amazon has requested, including:
-Bilingual images of all six sides of my Health Canada–licensed packaging
-English and French Instructions for Use approved by Health Canada and physically included in the box
-A copy of my official Health Canada Medical Device Licence
-A screenshot of the active MDALL listing
-An email from the Manager of Device Licensing Services at Health Canada, confirming my licence is active and valid
I continue to receive vague, copy-paste responses from the Medical Device Compliance Team stating that the “product detail page contains insufficient information.” I have already updated the product detail page, added the model number, and uploaded all required images.
I appreciate you sharing your situation surrounding this listing being removed. As noted this was due to the device being identified as a medical device requiring specific documentation. I also understand that you have repeatedly received the same rejection and request for more information. I have taken a look over your situation and provided cases, I was able to identify a specific concern.
At this time our teams do not have the confidence in reinstating the ASIN ending in "HCP5". This ASIN was identified as a class III medical device and is not permitted for sale on Amazon Canada. Looking over the ASIN I do see the specific mention of features unique to a class III device. Although this is not the outcome you're looking for at this time, but I wanted to provide this clarification.
The forums community and I are here to support you. Please let us know how we can help you from this point forward.
Emet.
