CLA-2-90:OT:RR:NC:4:405
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 implantable drug infusion pump systems from Switzerland and Japan
Dear Mr. Peterson, and Mr. Semmel:
In your letter dated March 2, 2012, for Medtronics, you requested a tariff classification ruling. No samples were provided.
Medtronic imports the IsoMed Constant-Flow Infusion System and the SynchroMedII Programmable Infusion System.
Per your submission,
“The drug infusion system consists of a pump and a catheter, both of which are surgically implanted into the body. The pump, placed into the abdomen, stores and delivers the pain medication, which is fed through a catheter that terminates at the spine. A doctor will refill the reservoir in the pump with medication when it runs low.”
You propose classification under HTSUS 9018.90.75 and 9018.90.80. However, while both items’ functions are somewhat similar to external means of delivering measured doses of medications, they are not used by the medical staff while they are treating the patient. They are intended to stay indefinitely inside patients while they go about their lives, with some limitations such as deep sea diving, contact sports, etc. The complete item is better described by the heading to HTSUS 9021 as Hearing Aids And Other Appliances Which Are Worn Or Carried, Or Implanted In The Body, To Compensate For A Defect Or Disability.
Harmonized System Explanatory Note V-4 includes, “Appliances implanted in the body, used to support or replace the chemical function of certain organs (e.g., secretion of insulin).”
We assume that the type of severe, prolonged pain that would result in such a major intervention as these implantations would be caused by a defect or disability. They are not “artificial parts of the body” elsewhere in HTSUS 9021 because they are not at all replacing a natural body part.
The applicable subheading for both items 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 pain that would be treated by such a major intervention would most likely be permanent or chronic and would indicate a physical 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 (in terms of HTSUS, Chapter 98, Subchapter 17, U.S. Note 4). 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 561940-KSG, dated February 7, 2001, which applied HTSUS 9817.00.96 to microscopes designed for use in eye surgeries such as retinal reattachment.
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 Russo
Director
National Commodity Specialist Division