Initial Importer question

[DeadPhoenix]

Hey ,

long time lurker and a lot of your posts already helped me a lot. So thanks for that. But this time I need some advice directly from you because I can't find a definite answer to my problem.

I work for a european company and we are also selling our products to the USA. We already have an initial importer and send our products to them for further distribution.
Now we have a customer (end customers/hospital) who urgently needs our products. Is it allowed to ship and bill our products directly to the customer?

The definition of the initial importer says that it's someone 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.

So if I apply this to my situation:
We would make the final delivery/sale of the device. Our customer is the ultimate user and therefore we wouldn't need an initial importer because the customer is the user and not someone that furthers the marketing of our device. The customer also doesn't need to be registred with the FDA. Therefore we can ship and bill to them directly.
Did I draw the right conclusions from this or did I misintepret something?

Thanks in advance.

 

[goldenguo]

You need a initial importer , this role response to FDA , and you need submit this initial importer to FDA ， you should have a FDA account to do this job, or contact your FDA agent to help;
And this initial importer need to pay to FDA every year , about 6000 USD.

Also there is a Importer of Recorder, this role response to ship, bank, US customs, for this situation, your customer is Importer of Recorder.

 

[Orca1]

Hey ,

long time lurker and a lot of your posts already helped me a lot. So thanks for that. But this time I need some advice directly from you because I can't find a definite answer to my problem.

I work for a european company and we are also selling our products to the USA. We already have an initial importer and send our products to them for further distribution.
Now we have a customer (end customers/hospital) who urgently needs our products. Is it allowed to ship and bill our products directly to the customer?

The definition of the initial importer says that it's someone 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.

So if I apply this to my situation:
We would make the final delivery/sale of the device. Our customer is the ultimate user and therefore we wouldn't need an initial importer because the customer is the user and not someone that furthers the marketing of our device. The customer also doesn't need to be registred with the FDA. Therefore we can ship and bill to them directly.
Did I draw the right conclusions from this or did I misintepret something?

Thanks in advance.

It is not allowed for a European company to ship and bill products directly to the end customer (hospital) in the USA. According to 21 CFR 807.3(x), an importer does not include the consumer or patient who ultimately purchases, receives, or uses the device, unless the foreign establishment ships the device directly to the consumer or patient. In your case, you already have an initial importer in the USA for further distribution.

To comply with the regulations, you should continue working with your initial importer, who is responsible for further marketing the device to the person who makes the final delivery or sale to the ultimate user, as defined in 21 CFR 807.3(g) and 21 CFR 803.3(j). The initial importer and distributors play a crucial role in ensuring compliance with the regulations and maintaining traceability within the supply chain, as stated in the MDR Article 13 and Article 14.