Importing a Demo Medical Device into the US

M

mghaleb

#1
#1
Hello everyone,

i have a question regarding Import demo medical device into US for Exhobition? must i register the demo device by FDA?

Thank and best Regard,
 
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M

Mark Meer

Trusted Information Resource
#2
#2
My understanding, is that as long as it is not going to be sold or used for clinical trials, there is no need to deal with the FDA.

Label the device appropriately (e.g. something like "For demonstration purposes only. Not intended for sale or distribution."), and include similar statement/designation on your commercial invoice, and you should be fine.
 
M

MIREGMGR

#3
#3
Note however that "demo" may imply some extent of procedural use. Use in human procedures would not be allowed.

...as long as it is not going to be sold
Click to expand...
Sale is not definitive of medical device marketing. Marketing also encompasses free samples, loans, and any other conveyance or provision that results in use in human procedures.
 
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