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cs@pineprep.com
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SERVICE
US FDA Medical Device
Certificate to Foreign Government (CFG)
Pineprep can obtain CFG documents for clients seeking medical device registration in various markets worldwide so that the proof of FDA compliance can be presented.
US FDA Certificate to Foreign Government
Many regulatory authorities in Asia, the Middle East, and Latin America require a submission of Certificate to Foreign Government (CFG) to authorize the sale of medical devices in their regions. This certificate officially proves that your device has received clearance or approval for the US market. Your CFG to these regulatory bodies can be submitted as part of your device registration process in their regions. Pineprep can assist you in accessing new markets by obtaining CFG documents from the US Food and Drug Administration (FDA) for your product on your behalf.
US FDA Certificate to Foreign Government
Many regulatory authorities in Asia, the Middle East, and Latin America require a submission of Certificate to Foreign Government (CFG) to authorize the sale of medical devices in their regions. This certificate officially proves that your device has received clearance or approval for the US market. Your CFG to these regulatory bodies can be submitted as part of your device registration process in their regions. Pineprep can assist you in accessing new markets by obtaining CFG documents from the US Food and Drug Administration (FDA) for your product on your behalf.
US establishments may request a CFG for any medical device that may be legally marketed in the US. A device may be legally marketed in the US if the following requirements are met:
- The establishment must be registered with the FDA
- The device must be listed with the FDA
- The device must have a cleared Premarket Notification [(510(k)] , an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or was granted a De Novo classification
- The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable
- The device must be manufactured in accordance with the Quality System (QS) regulation of 21 CFR 820, unless exempted by regulation
Process for Obtaining CFG
The US FDA directly issues CFG documents to companies with US-based offices or third-party service providers like Pineprep representing the foreign establishments. An application must be submitted to FDA requesting the CFG along with other requested information. Pineprep has the expertise and resources to obtain your CFG from the FDA on your behalf. Various markets Pineprep can procure CFG documents for clients include but are not limited to the following:
ASIA
China
India
Indonesia
Japan
Philippines
South Korea
Sri Lanka
Taiwan
Thailand
Vietnam
China
India
Indonesia
Japan
Philippines
South Korea
Sri Lanka
Taiwan
Thailand
Vietnam
MIDDLE EAST
Egypt
Iraq
Israel
Jordan
Kuwait
Lebanon
Morocco
Qatar
Saudi Arabia
Turkiye
United Arab Emitrates
Egypt
Iraq
Israel
Jordan
Kuwait
Lebanon
Morocco
Qatar
Saudi Arabia
Turkiye
United Arab Emitrates
LATIN AMERICA
Argentina
Bolivia
Brazil
Chile
Colombia
Cuba
Ecuador
Mexico
Oman
Peru
Uruguay
Argentina
Bolivia
Brazil
Chile
Colombia
Cuba
Ecuador
Mexico
Oman
Peru
Uruguay
OCEANIA
Australia
New Zealand
Australia
New Zealand
Cost of Obtaining CFG
CFG is product specific and its cost can vary depending on the number of official copies requested. FDA charges a fee for the first, original certificate and a different fee for each subsequent certificate from the same request. Certificates are provided on anti-counterfeit paper with an embossed gold seal.
We generally recommend ordering multiple copies when you first register a product in the FURLS database instead of waiting until you need it as the process of obtaining CFG can take longer than expected. However, be aware that a CFG is valid for 2 years from the date of issuance.
Pineprep, serving as the US Agent for numerous medical device companies, facilitate the acquisition of your CFG from the FDA. Our US-based team has been managing FDA interactions on behalf of clients, ensuring swift and effective procurement of CFGs. With our presence in the US, we bring specialized expertise to streamline the process.
We offer a diverse range of regulatory services.
Our services are focused on assisting medical device and IVD companies achieve regulatory and standard compliance.
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