CBP Finds Country of Origin for Needle Electrodes Is Either US or Japan, Based on Country of Manufacture

Needle electrodes from the U.S. or Japan that are sent to China for further processing remain products of the U.S. or Japan, CBP said in a ruling. Rhythmlink International, a manufacturer and distributor of medical devices, requested a final determination from CBP on the country of origin. Specifically, the company asked about "a Subdermal Needle Electrode," which is classified by the Food and Drug Administration as “a device which is placed subcutaneously to stimulate or to record electrical signals.”

The electrodes are made up of six components and Rhythmlink outsources the actual production either in the U.S. or Japan using stainless steel from the respective country. CBP found that the "qualities of the needle electrode itself" are not changed "as a result of the Chinese assembly and processing operations." Before any Chinese "assembly or processing, the needle electrode already meets the definition of the FDA regulated 'needle electrode,'" CBP said. As a result the country of origin is based on the country where the manufacturing of the needle electrode took place, whether the U.S. or Japan.

(Federal Register 07/31/18)