Certificates to Foreign Governments (CFG) foreign manufacturer

SteTop

Starting to get Involved
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.
 

Nichole F

Starting to get Involved
I believe you would need a CFG-NE in your case.
From FDA's website: "A CFG-NE is a document prepared by the FDA that may be issued for medical devices that are manufactured outside of the United States (OUS) and are shipped to another OUS country."
 

Belinda Lin

Medical Device RA
A Certificate to Foreign Government for Device Not Exported from the United States (CFG-NE) may be issued for medical devices manufactured outside of the U.S. that are cleared, approved, or are not required to submit a premarket report, and are shipped from outside of the U.S. to another foreign country provided certain conditions are met. Just search for it on the FDA website.

If you don't have a CFG, an FSC from Europe will also be accepted by Mexico, if your device has been CE marked.
 
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