9813.00.30/Medical Device Prototype Stent/Japan

Medical Device Prototype Stent from Japan

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 — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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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