CLA-2-30:OT:RR:NC:2:238
Samuel L. Morris III MILSPORT Medical, LLC
1865 Kenmore Avenue Buffalo, NY 14217
RE: The tariff classification of a Wound Guard medical device from China
Dear Mr. Morris:
In your letter dated April 9, 2010, you requested a tariff classification ruling. A sample, not the precise article that will be imported, but a “close representative of the finished article,” was provided. The sample is packed as an individual piece, apparently ready for direct use without repacking. Descriptive literature was also provided. We are retaining the submitted sample for our files.
The patent literature states that the Wound Guard device relates generally to bandages for covering wounds and, more particularly, to bandages with protective structures that shield wounds from further injury and promote healing. You state that the Wound Guard device may be imported in various shapes and sizes. The padded foam section is divided into pieces of various shapes that are “pluckable” so that the Wound Guard can be customized for different sized wounds without coming into contact with the wound itself. The liner is designed to allow oxygen in while shielding the wound from bumps and pressure or other further injury, and to promote healing. The underside of the pad is provided with an adhesive which allows for adherence to the skin. You further describe the article as a medical device intended for use in a medical setting such as a hospital or doctor’s office.
The applicable subheading for the Wound Guard medical device will be 3005.10.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices) … put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes: Adhesive dressings and other articles having an adhesive layer: Other.” 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/.
You also “request advice on labeling and marking requirements for this article.” You state only that the article will be “wholly imported from China.” This is insufficient for us to provide any extensive advice on this particular product. You do not describe the actual condition and/or packing as the product will be imported. The sample contains no marking at all. Proper country of origin marking depends on a number of factors, such as packing method, ultimate purchaser, etc.
Generally, the marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article.
Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandates that the ultimate purchaser in the U.S. must be able to find the marking easily and read it without strain. Section 134.1(d), defines the ultimate purchaser as generally the last person in the U.S. who will receive the article in the form in which it was imported. If an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser. In this case, the ultimate purchaser of these medical devices may be the hospital which, or the medical professional who, purchases the product at retail.
An article is excepted from marking under 19 U.S.C. 1304 (a)(3)(D) and section 134.32(d), Customs Regulations (19 CFR 134.32(d)), if the marking of a container of such article will reasonably indicate the origin of such article. Accordingly, if Customs is satisfied that the article will remain in its container until it reaches the ultimate purchaser and if the ultimate purchaser can tell the country of origin of the medical devices by viewing the container in which they are packaged, the individual device would be excepted from marking under 19 U.S.C. 1304 (a)(3)(D) and 19 CFR 134.32(d). Accordingly, marking the container in which the medical devices are imported and sold to the ultimate purchaser in lieu of marking the article itself is an acceptable country of origin marking for the imported medical devices provided the port director is satisfied that the article will remain in the marked container until it reaches the ultimate purchaser.
Drugs and medical devices are also subject to special labeling requirements by the U.S. Food and Drug Administration (FDA). Such merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the FDA. Information regarding the requirements (including labeling) of the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
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 Harvey Kuperstein at (646) 733-3033.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division