The country of origin of spinal and epidural needles

N350152 July 10, 2025 OT:RR:NC:N3:135 CATEGORY: Origin Sanjiv Kumar MYCO Medical Supplies, Inc 2015 Production Drive Apex, NC 27539 RE: The country of origin of spinal and epidural needles Dear Mr. Kumar: In your letter dated June 12, 2025, you requested a country of origin ruling. A sample of a spinal needle (SN22G351, 22G x 3.5”) and a sample of an epidural needle (TUFW17G351, 17G x3.5”, Tuohy – Fixed Wing Needle) were received, examined, and disposed of. The spinal needle and epidural needle are used to inject local anesthetics into a patient to provide regional anesthesia. Each needle consists of a stainless-steel shaft with a bevel (you refer to it as a cannula), a stainless-steel stylet, a plastic cannula hub, a plastic stylet hub, and a needle protector. You describe the manufacturing process as follows: 1. Production in Japan: Stainless-steel hollow tubes are cut to length and sharpened to form the cannula. Some cannulas are etched with depth markings to indicate insertion depth. A silicone coating is applied to the cannula surface. The blunt end of the cannula is sand-blasted to enhance adhesion to the plastic hub. The stylet is manufactured from solid stainless-steel wire using a similar process. All of the above processes, including the sourcing of raw materials for the cannula and stylet, are performed in Japan. 2. Assembly in China: The Japanese-origin cannula and stylet are exported to China. Plastic hubs, sourced from either China or Japan, are affixed to the cannula and stylet using adhesive glue of Japanese origin. A needle protector, molded in China using Japanese raw materials, is assembled onto the cannula. The completed needles are packaged in units of 100, placed in plastic bags, and then boxed in cardboard cartons. Both the plastic bags and cardboard boxes are sourced in China. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). Based on the information provided, the assembly operation occurring in China is a minor process. The Japanese cannulas and stylets do not substantially transform into new articles of commerce. They retain their own identity having the same name, character, and use after the assembly. Accordingly, we find the country of origin for the spinal and epidural needles is Japan. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division