The Egyptian Drug Authority — represented by the Central Administration for Medical Devices — announces the adoption of the following regulations in cases where there is a discrepancy between the country of origin stated on labels and invoices and that mentioned in the Certificate of a Foreign Government (CFG):

This applies specifically to medical devices and supplies holding a U.S. CFG certificate issued by the USFDA and submitted to the Central Administration for Medical Devices for import approval.

In such cases, the regulations issued by the U.S. Customs and Border Protection (CBP) shall be followed, whereby the country of origin stated on the invoice shall be considered the country of Last Substantial Transformation.

It is required in this case to submit an official letter from the legal manufacturer explaining the reason for this discrepancy, in accordance with CBP regulations.

Accordingly, the Central Administration for Medical Devices urges all representatives of importing companies to comply with the above-mentioned regulations and ensure the submission of the required official documents.