O
orangeisenergy
Hello,
We manufacture both human and animal IVD medical devices. We are currently working on entering the Panama market. The distributor is handling the process for us, but they are requesting a Certificate of Free Sale (called Certificate to Foreign Government) that is issued by the Department of Health and Human Services of the FDA. Since the devices in question are for veterinary use, they are not on our Certificate to Foreign Government, and cannot be listed on it. But the regulatory authorities in Panama are insisting that we have a certificate issued by DHHS.
Has anyone ever had this problem or have any suggestions of another regulatory body to get a certificate of free sale for our veterinary products from in the US?
We manufacture both human and animal IVD medical devices. We are currently working on entering the Panama market. The distributor is handling the process for us, but they are requesting a Certificate of Free Sale (called Certificate to Foreign Government) that is issued by the Department of Health and Human Services of the FDA. Since the devices in question are for veterinary use, they are not on our Certificate to Foreign Government, and cannot be listed on it. But the regulatory authorities in Panama are insisting that we have a certificate issued by DHHS.
Has anyone ever had this problem or have any suggestions of another regulatory body to get a certificate of free sale for our veterinary products from in the US?
