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Struggling with definition of Initial Importer and First Title

SGquality

Quite Involved in Discussions
#1
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" ?
 

sreenu927

Quite Involved in Discussions
#3
Hi SGQuality,

From my view, the warehouse at San Diego- US is considered as an "initial importer" and requires establishment registration per FDA regulations.

When your contract manufacturer ships the products to San Diego address, this address takes "first title" to US Customs. From the initial importer, products can be distributed to several distributor or warehouses within US and then to users/customers or directly to users/customers.

Regards,
Sreenu:2cents:
 
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