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Importing Medical Devices | FDA

    https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices
    Registration and listing. Establishments that are involved in the production and distribution of …

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 …

Importing Medical Devices Into The US: What You …

    https://usacustomsclearance.com/process/importing-medical-devices-into-the-us/
    In order to safely bring your medical devices into the U.S., you’ll need to strictly adhere to all of the …

United States Legal Framework for the Import of Medical …

    https://www.barnesrichardson.com/4E8FDC/assets/files/News/Revised%20Legal%20Framework%20for%20the%20Import%20of%20Medical%20Supplies.pdf
    The Premarket Notification process requires that medical device manufacturers or exporters register and notify the FDA at least 90 days in advance of either: 1) bringing into …

Importers – The European Union Medical Device …

    https://eumdr.com/importers/
    Importers. An importer is defined as being any natural or legal person established in the EU that places a device from a third country on the EU market. MDR/IVDR Article 13 …

US Initial Importers - QARA

    https://www.qaraconsultinggroup.com/post/foreign-device-establishments-us-agents-medical-device-reporting
    The Initial Importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported …

MDR (Medical Device Regulation) - NHRA

    https://www.nhra.bh/Departments/MDR/
    First, before importing or registering medical devices, you must be registered as an authorized representative in NHRA by applying and obtaining a license to import and register …

The import of medical devices in Italy - Di Renzo Regulatory Affairs

    https://www.direnzo.biz/it/en/custom-medical-device/
    The concept of “import” is not precisely straightforward, even if it is considered trivial. Initially “import” meant the transit of products through a country border. However, the …

Importing Medical Devices - 5 Key Factors to Ensure

    https://www.complianceonline.com/resources/importing-medical-devices.html
    Importing Medical Devices - 5 Key Factors to Ensure Regulatory Compliance. Comply with FDA regulatory requirements to ensure a trouble-free medical device import process. …

U.S. Medical Devices: Imports and Exports, …

    https://www.fimeshow.com/en/overview/industry-insights/US-medical-device-imports-exports.html
    Medical device lobbying group AdvaMed has expressed concerns about the effect of the trade war on U.S. medical device manufacturers. The medical device industry has …



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