Medical Device Prototype Stent from Mexico

Drug-eluting coronary stent prototype with experimental polymer coating for benchtop and animal model testing. Imported by medical device company for regulatory submission fatigue testing. 9813.00.30 for experimental medical device development.

Duty Rate — Mexico → United States

10%

Rate breakdown

9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter

Import Tips

FDA IDE number and test protocol mandatory for clearance

Include animal study approvals and destruction plans

Small quantities only - production lots trigger Chapter 90 classification