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Medical Device User Fee Amendments (MDUFA) | FDA

    https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
    Medical Device User Fee Amendments (MDUFA) User Fees for FY2023 Annual Establishment Registration Fee: $6,493 All establishments must pay the establishment registration fee. There are no...

Medical device application and report forms - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
    Application for a Medical Device Licence Amendment for a Private Label Medical Device; New Class III Medical Device Licence Application Form; Application …

Medical Devices Licence Amendment Minor Change …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-back-form-guidance-manufacturer.html
    Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences …

Application for a Medical Device Licence Amendment for …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/application-medical-device-licence-amendment-private-label.html
    Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only; …

Medical Devices Licence Amendment Fax-back Form

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-form-guidance.html
    Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only; Medical …

Frequently Asked Questions about Licensing - Medical …

    https://www.dshs.texas.gov/medical-device-manufacturers-distributors/licensing-requirements-medical-device-manufacturers-distributors
    To be eligible for a Multiple Products License, you must be distributing at least two of the following products: medical devices, food, nonprescription drugs, and compressed …

Guidance documents – Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html
    Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in …

Medical Devices Regulations ( SOR /98-282) - laws …

    https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/
    32 - Application for a Medical Device Licence 32.1 - Quality Management System Certificate 33 - Foreign Manufacturers 34 - Application for a Medical Device Licence …

HSA | Amend a medical device dealer's licence

    https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
    Amend a medical device dealer's licence You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification …

Health Canada Medical Device License Amendment

    https://connect.raps.org/discussion/health-canada-medical-device-license-amendment
    Health Canada Medical Device License Amendment | Regulatory Open Forum Home Events Volunteer RAPS.org Regulatory Open Forum Community Home 49.2K Library …



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