FDA CFG：医療機器輸出証明書

Does your export need an FDA CFG? Foreign customers and governments often ask exporters for proof of a device's U.S. status. For legally marketed devices, that proof is a CFG. A Certificate to Foreign Government is only for devices that can be legally marketed in the U.S.: cleared, approved, granted De Novo, exempt, or on the market before May 28, 1976. Other devices use a Certificate of Exportability. When you apply online, you certify that the establishment is registered, each device is listed and legally marketed, and none is the subject of an open recall. You also list recalls from the past 10 years. The fee is set. $175 for the first certificate, $85 for each extra one in the same request, invoiced quarterly. Then you get one download, within 45 days. Start with three things. One: fix registration and listing first. Two: name every manufacturer involved, including contract sterilizers and relabelers. Three: print in color if your market needs an apostille. No U.S. status, no CFG. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.