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Hi,
we're going to import a Class II medical device with a 510(k) Exempt into the US and sell it on Amazon. We are both manufacturer and exporter of the product and we will be getting an FDA registration in October.
Meanwhile, we need to solve an Initial Importer question. Usually for a non-FDA products, a foreign entity can act as an Importer of Record and get the shipment into the US. However, as we understand here, for a medical device we need to get a special "Initial Importer" entity who is also registered with the FDA.
Now, we have two options:
1, Either create our own US company, register it with the FDA and be our own Initial Importer. The problem is we need a physical presence with an actual office and people which we will hopefully eventually do, but right now it is an overkill.
2, Or get an existing Initial Importer to handle import and Medical Device Reporting duties for us.
The problem is - I can't find any company like that. It was easy to find an US Agent for the FDA registration, but I struggle with an Initial Importer entity. Does anyone know a company like that please?
Also, if we get an established Initial Importer in the US - is it necessary to physically send the goods to him or is it OKAY to use Amazon as our Ultimate Consignee and send the product directly to their warehouse?
Any other tips regarding import of a medical device into the US are welcome.
Thank you.
we're going to import a Class II medical device with a 510(k) Exempt into the US and sell it on Amazon. We are both manufacturer and exporter of the product and we will be getting an FDA registration in October.
Meanwhile, we need to solve an Initial Importer question. Usually for a non-FDA products, a foreign entity can act as an Importer of Record and get the shipment into the US. However, as we understand here, for a medical device we need to get a special "Initial Importer" entity who is also registered with the FDA.
Now, we have two options:
1, Either create our own US company, register it with the FDA and be our own Initial Importer. The problem is we need a physical presence with an actual office and people which we will hopefully eventually do, but right now it is an overkill.
2, Or get an existing Initial Importer to handle import and Medical Device Reporting duties for us.
The problem is - I can't find any company like that. It was easy to find an US Agent for the FDA registration, but I struggle with an Initial Importer entity. Does anyone know a company like that please?
Also, if we get an established Initial Importer in the US - is it necessary to physically send the goods to him or is it OKAY to use Amazon as our Ultimate Consignee and send the product directly to their warehouse?
Any other tips regarding import of a medical device into the US are welcome.
Thank you.
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