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A History of Medical Device Regulation and Oversight in …

    https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
    Authorized the FDA to ban devices 1977: The Bureau of Medical Devices and Diagnostic Products was renamed the Bureau of Medical Devices 1990: Safe Medical Devices Act …

Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It …

Medicines and Healthcare products Regulatory Agency

    https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency

    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 …

    Safeguarding public health

      https://www.adam-aspire.co.uk/wp-content/uploads/2011/02/mhra-medicines-and-medical-devices-regulation.pdf
      Safeguarding public health through the effective regulation of medicines and medical devices What is the MHRA? The Medicines and Healthcare products Regulatory …

    Managing Medical Devices - GOV.UK

      https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/982127/Managing_medical_devices.pdf
      medical devices are covered in separate documents. Medical devices play a key role in healthcare, vital for diagnosis, therapy, monitoring, rehabilitation and care. Effective …

    Ministerial Ordinances | Pharmaceuticals and Medical …

      https://www.pmda.go.jp/english/review-services/regulatory-info/0001.html
      Ministerial Ordinance on Good Clinical Practice for Drugs (as amended, effective December 28, 2012) Ministerial Ordinance on Good Clinical Practice for Medical …

    Managing medical devices - GOV.UK

      https://www.gov.uk/government/publications/managing-medical-devices
      This document outlines a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair …

    Medicines and Healthcare products Regulatory Agency

      https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
      The Medicines and Healthcare products Regulatory Agency (MHRA) has received a total of £970,688 from BEIS’ Regulators’ Pioneer Fund for three projects that aim to unlock …

    Medical Device Alerts - MDA's - 2003 - 2012 - Health

      https://www.health-ni.gov.uk/articles/medical-device-alerts-mdas-2003-2012
      Medical Device Alert: Implantable cardioverter defibrillator (ICD) leads Manufactured by St Jude Medical. This Medical Device Alert has been issued as there is …



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