Does your medical device require sterilization? The new ISO 11135:2014 is becoming more recognized as the international standard for the process management and validation requirements...
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 | Russia |
| Bolivia | Israel | Saudi Arabia |
| Brazil | Japan | South Korea |
| Chile | Jordan | Sri Lanka |
| China | Lebanon | Syria |
| Colombia | Mexico | Taiwan |
| Ecuador | Oman | Thailand |
| Egypt | Peru | United Arab Emirates |
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
