Obtaining a Medical Device CFG (Certificate to Foreign Government) from FDA
A Certificate to Foreign Government (CFG) is required by many medical device market regulators in Asia, the Middle East, and Latin America in order 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. Emergo has obtained CFG documents for many clients seeking new markets and can procure a CFG from the US FDA on your behalf.
The process for 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, Emergo has the expertise and resources to successfully procure your CFG from the FDA on your behalf. Markets for which Emergo has obtained CFG documents for clients include:
| Argentina | India | Qatar |
| Australia | Iraq | Saudi Arabia |
| Bolivia | Israel | South Korea |
| Brazil | Japan | Sri Lanka |
| Chile | Jordan | Syria |
| China | Lebanon | Taiwan |
| Colombia | Mexico | Thailand |
| Ecuador | Oman | United Arab Emirates |
| Egypt | Peru |
Emergo can obtain your CFG from the FDA
Emergo acts as US Agent for hundreds of medical device companies 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 have offered US Agent authorized representation services since 1997.
- 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.
Please contact us for more information on our Certificate to Foreign Government (CFG) service for US Agent clients.
Additional worldwide services:
- Certificate of Free Sale (CFS) for Medical Device Exports
- Clinical Trial Management for Medical Devices
- Customized Regulatory Pathway Reports for Smaller International Markets
- Medical Device Representative for In-Country Representation
- ISO 13485 Auditing | Medical Device Internal Audits
- ISO 13485 Consulting and Certification
- ISO 14971 Medical Device Risk Management
- ISO 14971 Medical Device Risk Management Training
- ISO 13485:2016 Gap Analysis and Transition
- Medical device software and mobile app regulatory consulting
- Quality Management System (QMS) Compliance for Medical Device Startups
- Medical Device Quality Assurance and Regulatory Affairs Outsourcing