Certificates to Foreign Governments (CFG) foreign manufacturer

[SteTop]

Hi all,

We are in process to register medical device in Mexico. Our distributor asked for "Certificates to Foreign Governments (CFG)".
Is it also applicable foreign manufacturers, registered with FDA and with 510k approved devices, although company is established in Europe?

Additionally, on the FDA web-site is stated:
By completing the required application, an establishment certifies that:

• The establishment is registered with the FDA;
• The device is listed with FDA;
• Each device may be legally marketed in the U.S.;
• Each device is not the subject of an open recall;
• All facilities involved in the manufacturing process are in compliance with FDA’s applicable regulations; and
• Each device is being exported from the U.S.

What means "Each device is being exported from the U.S."? Does that means that every time we will send device, we should export to U.S. and hen from U.S. to Mexico for example (or other country)?

Thank you.