Hello Oslap,
did you find the answer/solution to your question. We are medical device manufacturer based in Germany.
As per what we were informed by the US agent who registered our 510 Exempt Class 2 medical device; we ourselves can be the importer (not the Initial Importer) for the medical device and deliver it directly to our potential customers (Hospitals, Clinics etc.).
I am also trying to find out the right way to import our medical device into the US by following the guidelines provided by the FDA i.e. registering on the ACE portal, obtaining the IR number from CBP etc.
DO you know if we ourselves can import the medical device without requiring the initial importer?
Any help or advice would be highly appreciated.
did you find the answer/solution to your question. We are medical device manufacturer based in Germany.
As per what we were informed by the US agent who registered our 510 Exempt Class 2 medical device; we ourselves can be the importer (not the Initial Importer) for the medical device and deliver it directly to our potential customers (Hospitals, Clinics etc.).
I am also trying to find out the right way to import our medical device into the US by following the guidelines provided by the FDA i.e. registering on the ACE portal, obtaining the IR number from CBP etc.
DO you know if we ourselves can import the medical device without requiring the initial importer?
Any help or advice would be highly appreciated.
did you finally go with an initial importer?
Thx,