Medical Devices & US TAA (Trade Agreement Act) Compliance - 2019

lilybef

Involved In Discussions
#1
Hi All,

I have a question about medical devices and TAA compliance. I wasn't sure if this was the correct forum. Our devices have carry cases and power adapters that are made in China and shipped to the US. The power adapter can be sold separately. Does anyone know how this works with being TAA compliant?

Thank you!:thanx:
Lilybef
 

Al Rosen

Staff member
Super Moderator
#3
Hi All,

I have a question about medical devices and TAA compliance. I wasn't sure if this was the correct forum. Our devices have carry cases and power adapters that are made in China and shipped to the US. The power adapter can be sold separately. Does anyone know how this works with being TAA compliant?

Thank you!:thanx:
Lilybef
The answer to your question might be in this article Medical Device Companies Face Severe FCA Penalties for TAA Violations | Perspectives | Reed Smith LLP
 

lilybef

Involved In Discussions
#4
Sorry Marc - Trade Agreement Act. TAA requires end products delivered to Government customers to be “substantially transformed” in either the U.S. or a “designated country” identified in the Federal Acquisition Regulation (“FAR”). One of the biggest countries that is not on the "designated country" list is China. “Substantial transformation” occurs when a product is transformed from its component parts into a new and different article of commerce, with a name, character, or use distinct from its components.
 


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