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I need to renew a product registration in China and one of the requirements is a Certificate to Foreign Government from FDA. However, some of the devices are manufactured OUS and will ship from the mfg. site. Form FDA 3613 now states the following on the Exporter's Certification Statement: Each product(s) identified for export is being exported from the United States. My question is how do I get a CFG-type document for the devices shipping from OUS? I really don't want to force everything to/through the US! This is a new requirement for me - my understanding was that a CFG was for product "legally marketed" in the US.
Any suggestions?
Any suggestions?