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  • 1.  Are IVDs included in MDSAP?

    Posted 22-Jan-2015 05:19
    Hi,
    Does somebody kindly tell me if  in-vitro diagnostics are inluded in the Medical Device Single Audit Program (MDSAP)?
    Kind regards,
    Toru

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    Toru Murakumo RAC
    General Manager, Regulatory Affairs
    LSI Medience Corporation
    Tokyo
    Japan
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  • 2.  RE: Are IVDs included in MDSAP?

    Posted 23-Jan-2015 08:30
    Yes as per the release I have; 

    "The Medical Device Single Audit Program (MDSAP) Pilot consortium Regulatory Authority Council (RAC) is pleased to announce that medical device manufacturers are invited to participate in the MDSAP Pilot.

    Under this pilot, manufacturers that market medical devices and in vitro diagnostics in Australia, Brazil, Canada, and the US can volunteer to be inspected by a MDSAP-recognized third-party organization."



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    Keri Froese RAC
    Quality Assurance Specialist
    Ottawa ON
    Canada
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    Original Message


  • 3.  RE: Are IVDs included in MDSAP?

    Posted 23-Jan-2015 09:20
    Yes!  

    http://fdaguidance.net/2015/01/medical-device-manufacturers-are-invited-to-participate-in-the-mdsap-pilot/


    Original Message


  • 4.  RE: Are IVDs included in MDSAP?

    Posted 23-Jan-2015 15:30

    Hello Toru,


    U.S. Food and Drug Administration will accept MDSAP audits as a substitute for routine FDA inspections, typically done every two years for all classes of medical devices and including in vitro diagnostic devices.


    Additional information for manufacturers can be found on:


    http://www.fda.gov/medicaldevices/internationalprograms/mdsappilot/default.htm


    Nazanin Shalchian-Gregoretti, M.D., M.S.





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    Nazanin Shalchian Gregoretti MD
    Lexington MA
    United States
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    Original Message


  • 5.  RE: Are IVDs included in MDSAP?

    Posted 23-Jan-2015 16:46
    FYI:

    It is worth noting that the FDA's inspection policy on medical device firms has been recently changed as "risk-based."

    Please refer to FDA inspection CPG or http://wp.me/P4xpOK-Hc 




    Original Message


  • 6.  RE: Are IVDs included in MDSAP?

    Posted 24-Jan-2015 22:25
    Dear All,

    Thank you very much for your reply and the useful information.

    Best regards,

    Toru

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    Toru Murakumo RAC
    General Manager, Regulatory Affairs
    LSI Medience Corporation
    Tokyo
    Japan
    -------------------------------------------


    Original Message


  • 7.  RE: Are IVDs included in MDSAP?

    Posted 25-Jan-2015 21:02
    Under this pilot, manufacturers that market medical devices and in vitro diagnostics in Australia, Brazil, Canada, and the US can volunteer to be inspected by a MDSAP-recognized third-party organization. 


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    Jinjie Hu PHD
    Senior Regulatory Scientist
    BCG Inc.
    Alexandria VA
    United States
    -------------------------------------------


    Original Message