Medisafe 1 Technologies Corp. (fka MFTH)

[kex0414]

Do they need FDA approval?

,,,, Next to the EPA the FDA is the most powerful agency in the U.S. The following is an actual recall from the FDA.
GE Healthcare T-Piece Circuits for the Giraffe and Panda. Think the hypo for humans won't need approval.

As for patents; there are International Patent Laws – Seems like China is tho only one that outright breaks those rules.