What do we need to do to export Class 1 Medical Devices to the USA?


We sell Class 1 Medical Devices, which come under the 510(K) exempt classification for the FDA.

If our business wanted to sell directly into the USA is it the case that we would have to ‘Register as an Establishment’ and renew this registration on an annual basis, or is it not as straight forward as that?

Do we need to do anything else?


Hi Sebastien,

Thanks for your question. We tend to get quite a lot of good respondents to questions regarding the FDA, so hopefully you’ll get some good answers.



Hi Sebastian

We would be able to assist you in this matter. As an International freight forwarder, we have a vast level of experience in helping companies set up direct distribution links with the US, and also have experience of working with companies within your industry.

We would like the opportunity to talk with you in more detail with regards to this. Please get in touch with Chris on 07926 279485

We hope to hear from you soon 🙂

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