We are a Contract Manufacturer in Mexico and ship our devices to a warehouse in San Diego, US for storage and based on our end customer request, ship the devices to their location in US.
With this background, I understand that an Initial Importer is "any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user" as per http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.htm
but our customers are pointing us to another definition of Initial Importer as facilities that take first title to a device imported into the United States) must list all manufacturers of the devices they are importing per http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm
Is the "first title" synonymous to storing the devices as in our case at San Diego ? Or is the customer who is responsible for selling the device termed as an "Initial Importer" ?
With this background, I understand that an Initial Importer is "any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user" as per http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.htm
but our customers are pointing us to another definition of Initial Importer as facilities that take first title to a device imported into the United States) must list all manufacturers of the devices they are importing per http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm
Is the "first title" synonymous to storing the devices as in our case at San Diego ? Or is the customer who is responsible for selling the device termed as an "Initial Importer" ?