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Medical Devices | FDA - U.S. Food and Drug Administration

    https://www.fda.gov/Medical-Devices
    Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a...

Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of …

How to Determine if Your Product is a Medical Device | FDA

    https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

    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 …

    Frequently Asked Questions about Licensing - Medical …

      https://www.dshs.texas.gov/medical-device-manufacturers-distributors/licensing-requirements-medical-device-manufacturers-distributors
      A manufacturer who also distributes other manufacturer’s devices at the same location, only needs to license as a device manufacturer. However, the licensing fee is based on the …

    Medical Device Manufacturers and Distributors | Texas …

      https://www.dshs.texas.gov/medical-device-manufacturers-distributors
      To become licensed as a medical device manufacturer or distributor, please visit the licensing requirements page, which outline options for online licensing and renewal as …

    How to License Your Medical Device …

      https://licensingconsultinggroup.com/how-to-license-your-medical-device-technology/
      Licensing and Med Tech Value: The closer your medical device technology is to market ready, the more value it has in terms of licensing. Or another way …

    Medical device licensing - Canada.ca

      https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html
      Medical device licensing - Canada.ca Canada.ca Health Drug and health products Licensing, authorizing and manufacturing drug and health products Medical …

    Medical Devices Active Licence Listing (MDALL)

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html
      The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device …

    Complete List of Licensed Products and Establishments

      https://www.fda.gov/vaccines-blood-biologics/complete-list-licensed-products-and-establishments
      Complete List of Licensed Products and Establishments. Information updated monthly, and current as of January 31, 2023.



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