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Exporting Medical Devices | FDA

    https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices
    Establishments exporting devices from the United States (U.S.) are often asked by foreign customers or foreign governments to supply proof of the devices’ regulatory or marketing status as regulated by the Food and Drug Administration (FDA). The Export Reform and Enhancement Act of 1996 authorized the FDA to iss… See more

Importing and Exporting Medical Devices | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/importing-and-exporting-medical-devices
    Importing and Exporting Medical Devices | FDA Importing and Exporting Medical Devices Foreign establishments that manufacture medical devices and/or …

Other Export Documents | FDA

    https://www.fda.gov/medical-devices/exporting-medical-devices/other-export-documents
    As per Section 802 (c) of the FD&C Act, the export of a medical device for investigational use in any Tier 1 country listed in Section 802 (b) (1) (A) (i) and (ii) of the FD&C Act may …

Import and Export of Investigational Devices | FDA

    https://www.fda.gov/medical-devices/investigational-device-exemption-ide/import-and-export-investigational-devices
    The export of investigational medical devices follows a two tiered system depending on the country to which the device is exported. Products may be exported under 802 of the Act …

These countries are restricting medical supply exports

    https://www.weforum.org/agenda/2020/04/wto-report-80-countries-limiting-exports-medical-supplies/
    Eighty countries and customs territories have banned or limited the export of face masks, protective gear, gloves and other goods to mitigate shortages since the coronavirus outbreak began, the World …

Accessing medical equipment in developing countries …

    https://link.springer.com/article/10.1007/s13243-018-0065-7
    Remanufacturers according to the FDA include those reprocessing of single-use medical devices, a process which in FDA’s assessment, alters the intended use of a medical device by changing it …

Free Trade or Medical Supplies: Do Countries Have to …

    https://www.csis.org/analysis/free-trade-or-medical-supplies-do-countries-have-choose
    As of April 16, 75 countries have either limited or banned medical exports, which only amplifies the effects of the U.S. decision. For example, India announced last week it planned to place additional …

Key Medical Supplies Exported From U.S. to Foreign …

    https://theintercept.com/2020/04/01/coronavirus-medical-supplies-export/
    Many countries moved swiftly to shore up supplies for a potential pandemic. Global Trade Alert reported that from January 1 through March 11, 24 countries, including South Korea and Germany,...

Question and Answer Document for Donating and …

    https://www.fda.gov/media/80536/download
    Drugs intended to be shipped to a foreign country as part of a humanitarian relief effort are considered exports, and therefore, need to meet certain legal requirements under the …

The world’s top 10 medical device exporters | Opportimes

    https://www.opportimes.com/the-worlds-top-10-medical-device-exporters/
    Medical devices. In general, the countries that are included in the top 10 exporters tend to coincide with the importers. There are some exceptions: Ireland and Mexico are only …



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