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  • 1.  Singapore's Cybersecurity Agency Outlines New Labeling System for Medical Devices

    Posted 12-Dec-2022 16:05

    Cybersecurity risks are now heightened by medical devices which are connected via the Internet and Intranet in hospitals and home networks. The Cybersecurity Agency Scheme for Medical Devices rates each device according to its cybersecurity risk. This scheme includes four designations of risk, levels 1-4, with level 1 being the lowest risk and levels above 1 being the higher risk. The different categories relate to the amount of testing the device has been through. Products with higher cybersecurity risk levels may need to meet stronger cybersecurity standards. Next month, there will be a meeting with government officials, medical associations, and industry to further outline the requirements needed for devices in the higher risk levels. Singapore's Cybersecurity Agency was first started in 2015 and is connected to the Singapore Prime Minister's office. Hopefully, this new labeling scheme will incentivize manufacturers to increase security early on during the development of their medical devices.



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    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda, MD
    www.pacificbridgemedical.com
    contact@pacificbridgemedical.com
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  • 2.  RE: Singapore's Cybersecurity Agency Outlines New Labeling System for Medical Devices

    Posted 13-Dec-2022 07:58
    Hi Ames

    Can you provide the link re: Singapore cyber?  I am in the middle of  updating various Regulatory plans , especially.in the areas of cyber, wireless and privacy regulations.

    Thanks, Ginger

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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  • 3.  RE: Singapore's Cybersecurity Agency Outlines New Labeling System for Medical Devices

    Posted 14-Dec-2022 01:33

    Hi Ginger,

    https://www.csa.gov.sg/News/Press-Releases/cybersecurity-labelling-scheme-for-medical-devices

    And more info yet to be announced.

    Best,

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    AnaCiric
    RA/QA Specialist
    Singapore
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  • 4.  RE: Singapore's Cybersecurity Agency Outlines New Labeling System for Medical Devices

    Posted 14-Dec-2022 08:43
    Ginger -- Hello....I sent you 2 links via the RAPS portal yesterday....thx,best,ames

    ------------------------------
    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda, MD
    www.pacificbridgemedical.com
    contact@pacificbridgemedical.com
    ------------------------------