Regulatory Open Forum

 View Only
  • 1.  Exporting Medical Device for Repair - Argentina

    Posted 25-Aug-2021 15:59
    Hello All, 

    our device is currently registered in Argentina as a Class III. Our Distributor is saying that they are not allowed to export broken medical devices so that we as the Manufacturer can repair them (in the USA) and then re-import the device into Argentina. If anyone is familiar with the regulations in Argentina, could you please confirm whether this is true or not or any alternative routes we could pursue? 

    thank you!

    ------------------------------
    Rebecca Tucek
    Melbourne FL
    United States
    ------------------------------


  • 2.  RE: Exporting Medical Device for Repair - Argentina

    Posted 27-Aug-2021 15:29
    Hi Rebecca,

    I briefly researched Argentine import/export requirements and couldn't find that exporting broken medical devices is restricted.  However, importing broken medical devices is restricted.

    This is a good resource:  https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_108560.asp

    Or you could ask the US commercial services officer directly:  U.S. Commercial Service – U.S. Embassy in Buenos Aires, Argentina: -Karen Ballard, Commercial Attache: Karen.Ballard@trade.gov -Liliana Paz, Sr. Commercial Specialist: Liliana.Paz@trade.gov.

    Good luck!


    ------------------------------
    Gretchen Upton
    RAC, CQA, CCRP
    QA/RA consultant
    San Antonio, TX
    ------------------------------