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Overview of Device Regulation | FDA

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
    Medical Device Listing - 21CFR Part 807 Manufacturers must list their devices with the FDA. Establishments required to list their devices include: …

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 …

Regulating medical devices in the UK - GOV.UK

    https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

    Global Regulatory Authority Websites - PDA

      https://www.pda.org/scientific-and-regulatory-affairs/regulatory-resources/global-regulatory-authority-websites
      Argentina: National Administration of Drugs, Foods and Medical Technology (in Spanish) Belize: Ministry of Health Bolivia: Ministry of Health and Social Welfare Brazil: Ministry of …

    List of regulatory agencies and foreign jurisdictions

      https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/list.html
      Dec 23, 2020

    Medical devices - Canada.ca

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
      Medical devices - Canada.ca Medical devices What's New Subscribe to our RSS Feeds Device Advice: e-Learning tool The term Medical Devices, as defined in the …

    Official Portal of Medical Device Authority …

      https://www.mda.gov.my/
      Official Portal of Medical Device Authority (MDA) Malaysia - Medical Device Authority (MDA) Announcement 1 2 3 4 5 Prev Next NEW RELEASE GUIDELINE DOCUMENT …

    National Medical Products Administration - NMPA

      http://english.nmpa.gov.cn/
      Mr Xu Jinghe Attends the “CIMDR - GHWP Session & International Drug Regulatory Authorities Dialogue”. On the evening of December 20, 2022, the "China International …

    Australian regulatory guidelines for medical devices …

      https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
      The Essential Principles (the Principles) are legislative requirements relating to safety and performance characteristics of medical devices, including in vitro …

    GHWP Leaders Stress Importance of Supporting …

      https://www.spa.gov.sa/viewfullstory.php?lang=en&newsid=2426950
      The meeting also was attended by representatives of the 33 regulatory bodies, international alliances and associations other than member states, such as the …



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