OBTAINING A MEDICAL DEVICE CERTIFICATE TO FOREIGN GOVERNMENT (CFG) FROM FDA


A Certificate to Foreign Government (CFG) is required by many medical device market regulators in Asia, the Middle East, and Latin America to legally sell your product in their territories. A CFG confirms that your device has been cleared or approved for sale in the US. You can present your CFG to regulators in these markets as part of your medical device registration process. FDA Consulting LLC has obtained CFG documents for many clients seeking new markets and can procure a CFG from the US FDA on your behalf.

PROCESS OF OBTAINING A CFG FOR YOUR MEDICAL DEVICE


The US Food and Drug Administration issues CFG documents directly to companies with offices in the US. With a strong presence in the US, FDA Consulting LLC has the expertise and resources to successfully procure your CFG from the FDA on your behalf.

Our FDA Consultant can obtain your CFG from the FDA


FDA Consulting LLC could act as US Agent for medical device companies that are selling their products in the US. Our US-based consulting staff can interact with the FDA on your behalf to obtain your CFG as efficiently and quickly as possible:

  • We offer US Agent authorized representation services.
  • We are present in both the US and many of the markets that require a CFG.
  • Our expertise in dealing with the FDA for CFG procurement ensures an efficient process.

We could help you to overcome the hurdles with import or help you obtain a Certificates to Foreign Governments (CFGs) when exporting to markets that rely on FDA “approval” for regulatory responsibility.

Please contact us for further information about our import and export activity relatedservices. We may be able to assist you.

We serve companies of all sizes and product classifications within your budget. Please contact us for a quote for your submission