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Exporting Medical Devices | FDA

    https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices
    Firms exporting a device under section 801(e)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act) must maintain records demonstrating that the device meets the requirements of 801(e)(1) as required by 21 CFR 1.101(b). 21 CFR 1.101(b) requires that all records must be maintained for the … See more

Medtech In Chile Currently Latin America’s …

    https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001
    The total market size of the medical device sector in Chile is about $1.7 billion and has grown a whopping 75 percent since 2017. The nation imports most …

Chile - Import Requirements and Documentation

    https://www.trade.gov/country-commercial-guides/chile-import-requirements-and-documentation
    Includes import documentation and other requirements for both the U.S. exporter and foreign importer. Last published date: 2022-09-30. The commercial forms …

Healthcare Resource Guide - Chile

    https://www.trade.gov/healthcare-resource-guide-chile
    The country’s annual healthcare expenditure amounts to approximately 5.2% of Chile’s GDP. President Piñera’s administration took office on March 11, 2018. His …

Medical devices - Regulation of medical devices in Chile

    https://www.brokering.cl/regulation-of-medical-devices-in-chile/
    According to article 3 of Decree 825/98, persons or companies that want at any title, to fabricate, import, commercialize or distribute medical devices need to obtain …

Healthcare Re - Export.gov - Home

    https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_108572.asp
    In 2018, medical device imports amounted to US$ 695 million with the following market share: The United States has approximately 39%, followed by Germany with 23%, and …

Healthcare Resource Guide: Chile - Export.gov - Home

    https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_092228.asp
    Since the implementation of the U.S.-Chile Free Trade Agreement, in 2004, medical devices/equipment, and pharmaceuticals enter Chile duty-free, provided a U.S. …

Regulation Of Medical Devices Chile

    https://www.mondaq.com/healthcare/497754/regulation-of-medical-devices-chile
    New System Of Processing Customs Destination Certificates For Medical Devices Without A Sanitary Registration Carey As of July 2, a Customs …

Exporting to Chile | A Trade and Export Guide | LAC

    https://www.latinamericancargo.com/exporting-to-chile-a-trade-and-export-guide/
    Most companies exporting goods to Chile have a closely tied in-country partner or a direct presence. Operating without a direct market presence is difficult due to regulatory …

Change for Importing Medical Devices Into …

    https://quickstat.quick.aero/blog/change-for-importing-medical-devices/
    Change for Importing Medical Devices Into Chile — New Documentation Required. 12 Jun, 2018 by Leo Harcha. TOPICS Regulatory Updates. Effective July 02, …



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