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Management of Applications for Medical Device Licences

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-licences-investigational-authorizations.html

    Guidance Document: Management of Applications for …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/policies/management-applications-medical-device-guidance-2019/document.html
      2.2 Tools, Guidance Documents, Policies, and Application Forms. Health Canada has published numerous tools, guidelines, policies, and application forms to …

    Guidance document : management of applications for …

      https://publications.gc.ca/site/eng/9.867727/publication.html
      Guidance document : management of applications for medical device licenses. Publication type : Monograph : Language [English] Other language editions : Format : …

    Overview of Device Regulation | FDA

      https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
      Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

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

      https://www.fda.gov/Medical-Devices
      Public Health Emergency Updates. Stay up to date as we continue to keep up our ongoing mission of protecting public health and spurring medical device innovation. "Our center …

    Medical Device Safety Program - California

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

    Health Canada Revises Device License Applications Guidance

      https://alvamed.com/blog/health-canada-revises-device-license-applications-guidance/
      Health Canada has revised the “Management of Applications for Medical Device Licenses” guidance document, which provides industry with information on how …

    Management Of Applications For Medical Device Licences

      https://dayofdifference.org.au/m-medical/management-of-applications-for-medical-device-licences.html
      Canada: Guidance on Management of Applications for Medical Device Licences has been updated. 31st July 2019; Global Regulatory Press; A revised version of the guidance …

    Medical devices: software applications (apps) - GOV.UK

      https://www.gov.uk/government/publications/medical-devices-software-applications-apps
      Details. Guidance on what a software application medical device is and how to comply with the legal requirements. Read our statement on the launch of the guidance. …

    HSA | Medical device registration and licensing tools

      https://www.hsa.gov.sg/medical-devices/tools
      Medical device registration and licensing tools. Use these tools to help you when registering your medical device and applying for a dealer's licence. Is it a medical …



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