Urgent Assistance Needed. Medical device Class 1. Bilingual label exist. MDEL not applicable. Amazon can't hear me
Case ID 16019651251
I'm manufacturer-based and operating in USA. Sell only Class 1 medical device on Amazon Canada to the ultimate consumers as end users. Product has bilingual information about product.
Photos of bilingual product packaging label uploaded on product page with clear all required information about product according to Guidance for the Labelling of Medical Devices
MDEL is not applicable to me, according to Guidance on Medical Device Establishment Licensing
All documents as proof that I'm manufacture and evidence have been provided, but Amazon does not hear me. It seems that they do not check documents or look at screenshots
After checking appeal, amazon continued sending same requirements :
--> Upload Photos of all sides of the bilingual product packaging label in English and French on the ASIN detail page
if you are not the manufacturer --> Provide a valid Medical Device Establishment License (MDEL) number and Attach your MDEL document from Health Canada
Account health specialists don't help
Urgent need help how to make Amazon hear you
Urgent Assistance Needed. Medical device Class 1. Bilingual label exist. MDEL not applicable. Amazon can't hear me
Case ID 16019651251
I'm manufacturer-based and operating in USA. Sell only Class 1 medical device on Amazon Canada to the ultimate consumers as end users. Product has bilingual information about product.
Photos of bilingual product packaging label uploaded on product page with clear all required information about product according to Guidance for the Labelling of Medical Devices
MDEL is not applicable to me, according to Guidance on Medical Device Establishment Licensing
All documents as proof that I'm manufacture and evidence have been provided, but Amazon does not hear me. It seems that they do not check documents or look at screenshots
After checking appeal, amazon continued sending same requirements :
--> Upload Photos of all sides of the bilingual product packaging label in English and French on the ASIN detail page
if you are not the manufacturer --> Provide a valid Medical Device Establishment License (MDEL) number and Attach your MDEL document from Health Canada
Account health specialists don't help
Urgent need help how to make Amazon hear you
7 replies
Ricardo_Amazon
Hello @Seller_O0ok0EP5KFE1q,
Ricardo from Amazon here.
I see on the case you shared, you received a communication on 9/30 that needs your attention. Please reply to the case so our Support team can further assist.