The tariff classification of a Deep Brain Stimulation (DBS) System from the Netherlands and Malaysia.

N229156 August 30, 2012 CLA-2-90:OT:RR:NC:N4:405 CATEGORY: Classification TARIFF NO.: 9021.90.8100, 9817.00.96 John M. Peterson Russell A. Semmel Neville Peterson, LLP Counsellors at Law 17 State Street – 19th Floor New York, New York 10004 RE:      The tariff classification of a Deep Brain Stimulation (DBS) System from the Netherlands and Malaysia. Dear Mr. Peterson and Mr. Semmel: In your letter dated July 31, 2012, on behalf of Medtronic Inc., you requested a tariff classification ruling. No samples were provided. The subject merchandise is described as “certain implantable brain neurostimulators used in the treatment of individuals suffering from certain movement disorders – a group of neurological conditions that cause abnormal, slow, or reduced voluntary or involuntary movements – specifically, Parkinson’s disease, essential tremor, or primary dystonia. Medtronic’s DBS system is the Active Therapy System (“Activa”). In its condition as imported, Activa consists of the neurostimulator, lead kits, extensions, and a programmer. The neurostimulator uses a battery and special electronic circuitry to produce and to control an electrical pulse that is carried via the extension and leads to the brain. The programmer is used to control the device and to adjust the stimulation settings.” The neurostimulator is described as “a surgically implanted, battery-operated medical device…similar to a heart pacemaker and approximately the size of a stopwatch” which delivers “electrical stimulation to targeted areas in the brain that control movement, blocking the abnormal nerve signals that cause tremor and PD symptoms.” The import thus blocks part of the abnormal output of the nervous system that controls various neuromuscular functions so that the output to the muscles will be more like that from a person who does not have the condition.   We agree that the applicable subheading for the Deep Brain Stimulation System will be 9021.90.8100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Appliances, other than hearing aids or pacemakers, 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. Regarding your claim of duty free treatment under HTSUS 9817.00.96, we believe that the tremors, etc that would be treated by such an intervention would most likely be permanent or chronic and would indicate a physical impairment which substantially limits one or more major life activities. Although HTSUS, Chapter 98, Subchapter 17, U.S. Note 4-b-iii excludes therapeutic articles, CBP has held that term to apply quite narrowly for the purposes of  HTSUS 9817.00.96. See, e.g., Headquarters Ruling Letter 557025, dated March 17, 1993, which explicitly determined that implanted heart pacemakers are not “therapeutic” for purposes of that note. On that basis, we agree that a secondary classification will apply for these items in HTSUS 9817.00.96, as specially designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped (except articles for the blind), free of duty and user fees (if any).  Note that the requirement that the importer prepare and file a U.S. Department of Commerce form ITA-362P has been eliminated via a notice from the International Trade Administration, published in the Federal Register of June 1, 2010.  Also note that this classification has no effect on any quota, visa, or restricted merchandise requirements or dumping/countervailing duties.   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, Thomas J. Russo Director National Commodity Specialist Division