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FDA CFG Certification


CFG

Ever wondered how to get your medical devices into the hands of doctors and patients overseas? While meeting the regulations of your destination country is crucial, proving your device's compliance with U.S. standards can be a hurdle as well. This is where the FDA's Certificate to Foreign Government (CFG) comes in.


What is an FDA CFG Certificate?

A CFG is a document issued by the Food and Drug Administration (FDA) that verifies a medical device has been legally marketed and complies the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the United States. It essentially tells foreign regulators: "Hey, this device is good to go in the US, you can trust it."


Why is an FDA CFG Certificate Important?

Many foreign countries require a CFG as part of their medical device registration process. By presenting a CFG, you demonstrate that your device has already undergone a rigorous approval process, expediting your entry into new markets.


Who Can Apply for a CFG?

Any U.S. establishment registered with the FDA that manufactures or distributes a legally marketed, FDA cleared medical device can apply for a CFG.This applies to Class I, II, or III devices.


Contact Us Today

Unsure where to start? Let Provision Consulting Group be your partner in CFG application process. Contact us today for a consultation and learn how we can help you prepare the basic step of medical device exportation.



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