Eligibility for duty-free treatment under Nairobi Protocol concerning the Neria™ Guard Infusion Set from Denmark.

N360966May 19, 2026CLA-2-90:OT:RR:NC:N3: 143
CATEGORY: Classification
TARIFF NO.: 9817.00.96
Steve ZisserZisser Customs Law Group9355 Airway Rd., Suite 1San Diego, CA 92154RE: Eligibility for duty-free treatment under Nairobi Protocol concerning the Neria™ Guard Infusion Setfrom Denmark.Dear Mr. Zisser:In your letter dated
April 23, 2026
, you requested a tariff classification ruling on behalf of Convatec, Inc.The Neria™ Guard Infusion Set is a subcutaneous system for continuous medication delivery via a portableinfusion pump. It features flexible tubing in various lengths, a connector for secure pump attachment, and asoft cannula at the patient end for insertion under the skin. Secure adhesive fixation and anti-kink tubingsupport patient-managed therapy in home and ambulatory settings. Designed exclusively for subcutaneoususe, it is not suitable for intravenous infusion and is ideal for long-term treatment of chronic conditionsoutside hospital environments.Neria™ Guard infusion sets are prescription medical devices distributed through specialized channels andrequire authorization from a licensed healthcare provider. They are primarily used for continuoussubcutaneous infusion therapies to treat chronic conditions such as Parkinson’s disease and PulmonaryArterial Hypertension (PAH), with about 95% of usage associated with these patients. The sets are used inconnection with FDA-approved prescription medications, including Vyalev (foslevodopa/foscarbidopa) andOnapgo (apomorphine hydrochloride), which address motor fluctuations in adults with advanced Parkinson’sdisease. Both Parkinson’s disease and PAH are chronic, progressive conditions requiring ongoing treatment.Parkinson’s disease is a chronic, progressive neurological disorder marked by motor impairment such astremors, rigidity, and difficulty with movement. PAH is a chronic, life-threatening condition in which affectsthe pulmonary arteries, resulting in significant limitation on breathing, physical exertion, and overallfunctional capacity.
In your submission you requested consideration of a secondary classification under 9817.00.96, HarmonizedTariff Schedule of the United Sates (HTSUS), which applies to articles and parts and accessories of articlesspecifically designed or adapted for the use or benefit of the permanently or chronically physically ormentally handicapped.Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of theblind or other physically or mentally handicapped persons; parts and accessories (except parts andaccessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in theforegoing articles . . . Other.” The term “blind or other physically or mentally handicapped person includes“any person suffering from a permanent or chronic physical or mental impairment which substantially limitsone 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 diagnosticarticles; 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 extentgreater than in other cases or towards others” and “designed” means something that is “done, performed, ormade with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” Wemust 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 Appealsfor the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” themerchandise “must be intended for the use or benefit of a specific class of persons to an extent greater thanfor 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 byproperties of the design, form, and the corresponding use specific to this unique design, from articlesuseful to non-handicapped persons); (2) whether any characteristics are present that create asubstantial probability of use by the chronically handicapped so that the article is easilydistinguishable from articles useful to the general public and any use thereof by the general public isso improbable that it would be fugitive; (3) whether articles are imported by manufacturers ordistributors 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 thehandicapped.The Neria™ Guard Infusion Set is specifically designed for use with portable infusion pumps to deliver acontrolled amount of medication for the management of chronic and progressive conditions such asParkinson’s disease and pulmonary arterial hypertension (PAH). This system enables patients toself-administer medication continuously outside a clinical setting. As you have noted, patients withParkison’s and PAH have symptoms that substantially impair movement and respiratory function, limitingthe major life activities such as walking, performing manual tasks, breathing, and caring for themselves.Based on the information provided, it is our opinion that patients suffering from Parkison’s and PAH areconsidered physically handicapped as defined in Chapter 98, Subchapter XVII, U.S. Note 4(a). The Neria™Guard Infusion Set is specifically designed for the benefit of such persons and is therefore eligible forduty-free treatment under subheading 9817.00.96, HTSUS.The 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 providedat https://hts.usitc.gov/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS.Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs.For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.The holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Dionisia Melman at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division