Certificate to foreign government FDA 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. For the registration process or for the approval process you need experience Medical device compliance and regulatory service provider who can work with you to solve the raised issue if any.
Before certain medical devices can be lawfully exported from the United States, some countries require American companies to obtain a Certificate to foreign government FDA (CFG). The FDA recently issued a final guidance titled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices,” which details how to seek review of the denial of a CFG request, as well as the reasons the FDA will deny such a request and how to rectify them.
Certificate to foreign government FDA are product specific and cost $175 for the original certificate. Each additional copy (official copies from the FDA are usually required) costs $15 per copy. Up to 50 pages (including the certificate, manufacturer page, and attachment pages) may be submitted for the same product. Each time an increment of 50 pages is exceeded, an additional fee of $175 will be charged.
If the original is three pages long and you request an original and ten copies (33 total pages), then your charge will be $175 for the original and $150 for the ten copies–a combined total of $325. However, original and 20 copies (63 pages) would exceed the 50-page limit, and you would be charged $175 for the first original and $225 for the first 15 copies. You would then be charged $175 for a second original and another $60 for four more copies.
Do not wait until the last minute to request Certificate to foreign government FDA I recommend ordering 5-10 copies when you first register a product in the FURLS database, instead of waiting until you need it. The same is true of other types of certificates, such as CE Marking certificates from your Notified Body.
What is a Certificate to foreign government FDA?
If you have a medical device that is registered and listed with the US FDA, then you can obtain a Certificate to Foreign Government from the US FDA.
A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States. Regulatory bodies in some countries request a “Certificate of Free Sale.” Still, these are issued by the US FDA for foods, while the agency issues Certificates to Foreign Governments for medical devices.
The name of the certificate is not the same for all countries, and regulators use the terminology most familiar to their country. A Certificate to foreign government FDA (CFG) is, for the export of medical devices that can be legally marketed in the United States (U.S.) that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.
U.S. establishments may request a Certificate to foreign government FDA for any medical device that may be legally marketed in the U.S. A device may be legally marketed in the U.S…
- 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.
A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States.
What is FDA registration?
FDA Registration mandated by the United States Food and Drug Administration responsible for protecting public health from various consumer products such as Drugs, Medical devices, Food & Cosmetics. Product registration plays a vital role in the path of a product that is on its way to the market. If FDA found your unregistered product, it will issue a cease and desist order removing the products from the market.
What is the difference between FDA approval and FDA registration?
REGISTRATION:
- Registration means FDA is aware of the manufacturer and their devices
- The manufacturer cannot claim the device is FDA CLEARED or APPROVED
- They cannot use FDA logo in labelling their device.
APPROVAL:
- FDA approval means high risk devices are well tested and approved.
- Class III medical devices fall under this category
- It requires a statement or a proof that the high risk devices is safe to use and manufacture.
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