The tariff classification of an Insulin Delivery Device exported from China

N193177 December 14, 2011 CLA-2-90:OT:RR:NC:4:405 CATEGORY: Classification TARIFF NO.: 9021.90.8100 Mr. Matthew McCullough Winston & Strawn 1700 K Street, N.W. Washington, DC 20006 RE: The tariff classification of an Insulin Delivery Device exported from China Dear Mr. McCullough: In your letters dated November 11 and December 9, 2011, for Valeritas, Inc., you requested a tariff classification ruling. Samples were provided. Diabetics secure the V-Go Insulin Delivery Device to their skin under their clothing. It supplies insulin in very small doses throughout the day via a built-in needle. The user can see into the reservoir to see the progress of the infusion. The EZ Fill filling accessory aids the user in transferring insulin from a vial into the V-Go. The V-Go and EZ Fill will be imported without any insulin. For both, you propose classification under HTSUS 9018.39 which provides for Instruments and appliances used in medical, surgical, dental or veterinary sciences, “other” Syringes, needles, catheters, cannulae and the like. However, neither is used in the professional practice of medicine by health care professionals and their function goes far beyond that of an ordinary syringe or needle. The V-Go is better described as an appliance which is worn or carried on the body to compensate for a defect or disability. Harmonized System Explanatory Note V-4 to 9021 includes a similar implanted item, i.e., “Appliances implanted in the body, used to support or replace the chemical function of certain organs (e.g., secretion of insulin).” Unlike the laryngectomy covers which Headquarters Ruling Letter 966874 AM, May 17, 2004, excluded from HTSUS 9021, V-Go’s “actively compensate for the defect or disability” and “assist or replace the function of a failed organ: … they pump insulin when the pancreas has stopped working.” Separately imported parts and accessories, if identifiable as suitable for use solely or principally as parts or accessories of this kind of device (see General Harmonized System Explanatory Note III to Chapter 90) or of this particular item (see Headquarters Ruling Letter 965546, 8-6-02), are classified in its heading if not excluded from HTSUS Chapter 90 by its Note 2-a or 1 or by HTSUS Add. US Rule of Interpretation 1-c (see HRLs 965968, 12-16-02, and 967233, 2-18-05.) From its rather elaborate construction and the need for precise matching to the V-Go, we consider the EZ Fill to be “identifiable” as a part or accessory to the V-Go and/or a similar insulin delivery device. We do not believe any of the above exclusions apply. The applicable subheading for the V-Go and EZ Fill will be 9021.90.8100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “other” appliances which are worn or carried, or implanted in the body to compensate for a defect or disability and parts and accessories thereof. The rate of duty will be free. 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 on World Wide Web at http://www.usitc.gov/tata/hts/. This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist J. Sheridan at (646) 733-3012. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division