The tariff classification and eligibility of Arterial Venous Fistula Needle Sets under the Nairobi Protocol Treatment from Indonesia

N350795 July 28, 2025 CLA-2-90:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9018.39.0050; 9817.00.96 Tirta Halim T Customs Broker, inc. 5777 W. Century Blvd. #965 Los Angeles, CA 90045 RE: The tariff classification and eligibility of Arterial Venous Fistula Needle Sets under the Nairobi Protocol Treatment from Indonesia Dear Mr. Halim: In your letter dated June 30, 2025, you requested a tariff classification ruling on behalf of JMS North America Corp. for Arterial Venous (“AV”) Fistula Needle Sets. Additional information was provided via email on July 22 and July 24, 2025. JMS Unguarded, JMS WingEater™, JMS SysLoc™, JMS SysLoc™ Mini, and JMS Harmony™ AV Fistula Needle Sets are singleuse sterile devices intended to cannulate an established AV fistula or graft for repeated extracorporeal blood treatments in patients receiving chronic (long term) renal replacement therapy. You state that all the Arterial Venous Fistula Needle Sets above may be used for conventional hemodialysis and, when clinically appropriate and consistent with labeling, for related modalities such as intermittent hemofiltration or hemodiafiltration that utilize the same extracorporeal circuit. You explain that hemofiltration and hemodiafiltration are both forms of renal replacement therapy and are subsets of dialysis, not separate or unrelated procedure and that the same vascular access needles used for standard hemodialysis are also used for these treatments. The AV Fistula needles are designed, labeled, and marketed for hemodialysis. JMS Unguarded AV Fistula Needle Set is a fully assembled device consisting of a needle cover, a stainless-steel needle, a plastic wing, a PVC tube, a plastic clamp, an AVF Joint/connector, and a Luer Lock cover. JMS WingEater™ AV Fistula Needle Set is a fully assembled device which consists of a needle cover, a stainless-steel needle, a folded plastic wing, flexible PVC tube, a plastic WingEater, a plastic clamp, a Female Luer connector, and a connector cover. The WingEater allows the wing and needle to retract within use and prevent needlestick injury. JMS SysLoc™ AV Fistula Needle Set and JMS SysLoc™ AV Mini Fistula Needle Set are fully assembled devices. Each consists of a needle cover, a stainless-steel needle, a plastic wing sheath, a rotating hub, a flexible PVC tube, a plastic clamp, a Female Luer connector, and a connector cover. JMS Harmony™ AV Fistula Needle Set is a fully assembled device which consists of a needle cover, a stainless-steel blunt needle, a plastic wing, a flexible PVC tube, a plastic clamp, a Female Luer connector, and a connector cover. In your letter, you suggest classification in subheading 9018.31.0090, Harmonized Tariff Schedule of the United States (HTSUS), which provides parts and accessories of syringes with or without needles. We disagree. The AV Fistula Needle Sets are similar to “needles, catheters, cannulae and the like...” and properly classified within subheading 9018.39.00. See HQ ruling 086015, dated January 10, 1990. The applicable subheading for the AV Fistula Needle Sets will be 9018.39.0050, HTSUS, which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: [s]yringes, needles, catheters, cannulae and the like; parts and accessories thereof: [o]ther: [o]ther.” The general rate of duty will be free. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time products from all countries will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9018.39.0050, HTSUS, listed above. However, the additional duties imposed by subheading 9903.01.25 shall not apply to goods for which entry is properly claimed under a provision of chapter 98 of the tariff schedule pursuant to applicable regulations of U.S. Customs and Border Protection (“CBP”), and whenever CBP agrees that entry under such a provision is appropriate, except for goods entered under heading 9802.00.80; and subheadings 9802.00.40, 9802.00.50, and 9802.00.60. In your submission you requested consideration of a secondary classification under 9817.00.96, HTSUS, which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles: [o]ther.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. In Headquarters Ruling HQ 964676, dated January 7, 2002, CBP determined that the specially produced P.E.S./P.E.T. bundles used in dialyzers for the treatment of chronic renal failure qualified for duty free treatment under subheading 9817.00.96, HTSUS. In the ruling, CBP confirmed that people who suffer from end-stage renal failure were considered handicapped, and articles specifically designed almost exclusively for their benefit were classifiable as articles for the handicapped, as established in Travenol Laboratories, Inc. v. United States, 813 F. Supp. 840, 844 (CIT 1993). In NY rulings 804233 and 804379, dated December 1, 1994, CBP ruled that the AV Fistula Needle Sets were eligible for duty-free treatment under subheading 9817.00.96, HTSUS. You state the subject AV Fistula Needle Sets are specially designed and intended for use by individuals with chronic kidney disease who require hemodialysis, a life-sustaining treatment typically performed multiple times per week. Based on the information supplied and the relevant precedent, it is the opinion of this office that the above AV Fistula Needle Sets qualify for duty-free treatment in subheading 9817.00.96, HTSUS. The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. 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