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Device Registration and Listing | FDA

    https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
    For assistance with registration and listing status, please contact the CDRH Registration and Listing Help Desk at: Phone: 301-796-7400. Email: [email protected]. For assistance with policy or ...

Medical Device Establishment Licence (MDEL) …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

    Establishment Registration & Device Listing - Food and …

      https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

      Guidance on Medical Device Establishment Licensing …

        https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html
        Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary. From Health Canada’s Regulatory Operations and Enforcement Branch. In light of COVID-19, …

      Medical Devices Establishment Licence Listing

        https://health-products.canada.ca/mdel-leim/index-eng.jsp
        The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and …

      Medical Device Safety Program - California

        https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/MedicalDeviceSafetyProgram.aspx
        Medical Device Safety Program. The Medical Device Safety Section's mission is to provide an uncompromising standard of public health protection by assuring that medical …

      MDEL Registration | Medical Device …

        https://qualitysmartsolutions.com/health-canada-medical-device-establishment-licence-and-class-i-ii-iii-iv-medical-device-licensing-solutions/
        A Medical Device Establishment Licence (MDEL) is an authorization granted by Health Canada to a person in order to manufacture, import, advertise or sell medical devices …

      Medical Devices Establishment Licenses – Drug Regulatory …

        https://www.dra.gov.pk/therapeutic-goods/licensing-and-inspections/medical-devices-establishment-licenses/
        Establishment License are valid for 05 years, until, unless revoked or suspended earlier. Application process for Medical Device Establishment License . …

      Medical Devices Establishment Licensing System - SFDA

        https://mdel.sfda.gov.sa/FAQs.aspx
        What is the Medical Device Establishment Licensing (MDEL) ? MDEL is a licensing system for medical devices establishments in Saudi Arabia. It is a web based system …



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