Importing medical device for use in fit testing of packaging

ScottK

Not out of the crisis
Leader
Super Moderator
We need to import some medical devices (orthopedic instruments) to measure and then use for fit testing in a case/tray/caddy system we will be designing for an overseas customer.

The customer is not registered with the FDA... and doesn't necessarily intend to register as the product will only be for sale in their country.

How do we get these through customs legally?

Do they need to be documented as medical devices or can they be documented as tools and samples for gauging?

thoughts?
 

ScottK

Not out of the crisis
Leader
Super Moderator
Thanks J0anne. I'm aware of that table.

The question here really is - are they medical devices?
They are not going to be marketed or sold in this country and we're using them only to take measurements and use as go/no-go gauges.

I guess it's more a customs question than an FDA question.
 
M

ManTheDan88

I think you get away with importing the devices labeled as "for research use only". Here's the link to the guidance document from the FDA:

(broken link removed)

Give Section II Part A a look.
 
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