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Exporting Medical Devices | FDA

    https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/exporting-medical-devices
    As of March 2014, the FDA does not notarize certificates. Please contact the U.S. Department of State for apostille and a certificate of authentication. You can request apostille and a certificate of authentication following the instructions at the links below: 1. Apostille Requirements 2. DS-4194: Request for Authenticatio… See more

Types of Export Certificates | FDA

    https://www.fda.gov/medical-devices/exporting-medical-devices/types-export-certificates
    A Certificate of Exportability (COE) under Section 801(e)(1) of the FD&C Act (COE 801) is for the export of medical devices that may not be legally marketed in the U.S. and that …

How to Request Export Certificates or Permits and How …

    https://www.fda.gov/medical-devices/exporting-medical-devices/how-request-export-certificates-or-permits-and-how-submit-simple-notifications
    Instructions can also be accessed on the CECATS Help Documentation webpage. If you have any questions regarding using CECATS, please email …

Create a Medical Device Certificate of …

    https://www.access.fda.gov/cecats/help/cecats-801-802-guide.html
    The Center for Devices and Radiological Health (CDRH) issues several types of Export documents. Select the Certificate of Exportability Section 801(e)(1) or the 802 …

Exporting Medical Devices Frequently Asked Questions …

    https://www.fda.gov/medical-devices/exporting-medical-devices/exporting-medical-devices-frequently-asked-questions-faqs
    An export certificate may be issued for medical devices being exported from the United States and includes a Certificate to Foreign Government, Certificate of Exportability and …

Create a Medical Device Certificate to …

    https://www.access.fda.gov/cecats/help/cecats-cfg-guide.html
    The Center for Devices and Radiological Health (CDRH) issues several types of Export documents. When creating a new application, select Certificate to Foreign Government …

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. Foreign establishments that manufacture medical devices and/or radiation-emitting electronic products that are …

Create a Medical Device Certificate for …

    https://www.access.fda.gov/cecats/help/cecats-cdne-guide.html
    Certificate for Device Not Exported from the United States (CDNE) A Certificate for Device Not Exported from the United States is issued for devices which: Are …

Certificate of Free Sale (CFS) for Medical Device Exports - Emergo

    https://www.emergobyul.com/services/certificate-free-sale-cfs-medical-device-exports
    Certificate of Free Sale (CFS) for Medical Device Exports. Emergo has obtained CFS documents for many clients seeking medical device registration in Asian, Middle Eastern, …

Guidance to apply for a Manufacturer's Certificate to …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/application-manufacturer-certificate-cover-export-medical-devices-0097.html
    Date issued: January 18, 2023 Date implemented: January 18, 2023 Replaces: Guidance to apply for a manufacturer's certificate to export licensed medical …



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