The country of origin of Epidural Needles

N353259
September 30, 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 Epidural Needles Dear Mr. Kumar: In your letter dated September 4, 2025, you requested a country of origin ruling on Epidural Needles. The provided sample has been reviewed and disposed of. Epidural Needles are medical devices used for the administration of anesthesia. Each needle consists of a stainless-steel shaft with a bevel (you refer to it as a cannula) , a plastic hub, plastic plunger, and a plastic needle protector. The provided Reli® Epidural Needles Datasheet indicates that the needles range from 16-gauge to 22-gauge and 2.5” to 6” in length. You describe the manufacturing process as follows: 1. Production in Japan: Stainless-steel hollow tubes are cut to length to form cannula. Tip of cannula is bent to produce an epidural point. Epidural point is grit blasted to ensure smooth heel on needle. The above processes, including the sourcing of raw materials for the stainless-steel cannula, are performed in Japan. 2. Assembly in China: The Japanese-origin cannula is exported to China. Plastic hub and plunger, made from raw materials sourced from Japan, are affixed to the cannula 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 and then boxed in cardboard cartons. The cardboard boxes are sourced in China. The primary function of the completed Epidural Needles is to inject local anesthetics into patients to provide regional anesthesia. They will only be used by trained healthcare professionals.

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 above-described manufacturing process, the assembly operations occurring in China do not result in a substantial transformation of the Japanese-origin cannulas into new articles of commerce. The Japanese cannulas retain their own identity having the same name, character, and use after the assembly process in China. Accordingly, we have determined that the country of origin of the 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 [email protected].
Sincerely,
(for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division