COUNTRY OF ORIGIN MARKING OF IMPORTED MEDICAL DEVICES

N098319 April 5, 2010 MAR-2 OT:RR:NC:N4:405 CATEGORY: MARKING Mr. Larry MatthewsMedtronic Operations3850 Victoria Street N.Shoreview, MN 55126 RE: COUNTRY OF ORIGIN MARKING OF IMPORTED MEDICAL DEVICES Dear Mr. Matthews: This is in response to your letter dated March 12, 2010, requesting a ruling on whether the proposed method of marking the container in which the medical devices are imported with the country of origin in lieu of marking the article itself is an acceptable country of origin marking for the imported medical devices. Marked sample containers were not submitted with your letter for review. In your submission you describe several medical devices that will be imported into the United States. All of the devices are marketed and sold specifically to hospitals and medical professionals, and all of them are shipped in a sealed, sterilized package labeled for distribution.The devices in question include Pacemakers and Implantable Cardiac Defibrillators (ICDs). These devices are designed to be implanted into a patient’s chest to treat heart afflictions. These pacemakers and ICDs are manufactured in Switzerland, Singapore, and Puerto Rico. Your submission also refers to Leads, which are designed for use with compatible ICDs and Pacemakers. The Leads are described as tiny insulated wires implanted into the body to carry signals between the heart and the ICD or Pacemaker. The Leads are manufactured in Puerto Rico. A Catheter and Catheter Delivery System will also be imported. The catheter is said to be a flexible tube made of latex or Teflon that can be inserted into the body to create a passage for the entry of a Lead. The Catheter Delivery System is described as a steerable system for cannulation and Lead delivery. These devices are manufactured in Ireland and Puerto Rico. The final device covered by your submission is called the Reveal Insertable Cardiac Monitor. This is a small implantable medical device that records cardiac activity during instances of irregular heart activity. The device captures an electrocardiogram and can transmit that information to a separate, handheld device. The Cardiac Monitor is manufactured in Puerto Rico. In your submission you propose marking the sealed, sterilized containers that the abovementioned devices are shipped in with the country of origin, rather than the devices themselves, and wish to confirm that this method is acceptable in accordance with 19 USC 1304. To support your case, you cite Headquarters Ruling Letter 560561 – MLR, July 24, 1997, which found that marking the packaging for sealed medical trays, rather than the individual components of the trays, was sufficient provided the ultimate purchaser would receive the trays in the marked packaging. You state that the devices you will be importing are marketed and sold specifically to hospitals and medical professionals, and that these medical professionals will receive the devices in the sealed, sterilized packaging with the country of origin information clearly displayed. It should be added that Headquarters Ruling Letter 731002 – JD, October 31, 1989, determined that the doctor or medical professional that implants certain medical devices would be considered the ultimate purchaser, and not the patient in which these devices are to be implanted. Furthermore, while you do not explicitly state this in your submission, it is likely that some of the devices you mention, like the leads, pacemakers, and ICDs, are so small as to make it difficult to clearly label the devices themselves with the country of origin, much like the hearing aids described in New York Ruling Letter N061761 – 405, June 12, 2009. 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 is 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. To clarify, under no circumstances is a country of origin marking required for the transfer of those items that are products of Puerto Rico for “importation” into the fifty states. Per Headquarters Ruling Letter 555062 CW, 2-23-90, “Since Puerto Rico is a territory or possession of the U.S., it is not subject to the requirements of 19 U.S.C. 1304.” This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 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