Medical Device NiMH Battery Pack from China

Sealed NiMH battery for portable medical equipment like defibrillators or infusion pumps. Classified HTS 8507.50.00.00 as nickel-metal hydride storage battery meeting medical standards. High reliability with built-in protection circuits.

Duty Rate — China → United States

38.4%

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
9903.88.0325%Except as provided in headings 9903.88.13, 9903.88.18, 9903.88.33, 9903.88.34, 9903.88.35, 9903.88.36, 9903.88.37, 9903.88.38, 9903.88.40, 9903.88.41, 9903.88.43, 9903.88.45, 9903.88.46, 9903.88.48, 9903.88.56, 9903.88.64, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(e) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(f)

Import Tips

FDA 510(k) or device listing may apply if considered medical device component

ISO 13485 quality certification documentation recommended

Enhanced testing for medical-grade batteries; provide failure rate data