Regulatory Open Forum

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  • 1.  IVDs in Sierra Leone

    Posted 13-Jul-2015 16:11
    Does anyone have any experience with IVD regulations in Sierra Leone?  Are there any registration requirements??

    Thanks!
    Joy


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    Joy Pelfrey
    Director of RA/QA
    Norman OK
    United States
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  • 2.  RE: IVDs in Sierra Leone

    Posted 14-Jul-2015 14:36

    Currently, South Africa only requires registration and CE Marking for electromagnetic and radiation-emitting devices. Licensing from the Directorate of Radiation Control are required in order to import electronic medical devices into the country. Market authorization for these devices in South Africa requires prior EU approval.


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    Robert Wilkinson
    President
    Resolute Regulatory Affairs Consulting Service, Inc
    Port Barrington IL
    United States
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    Original Message


  • 3.  RE: IVDs in Sierra Leone

    Posted 14-Jul-2015 15:10
    I would recommend you have a chance to visit Pan African Harmonization Work Party on Medical Devices and Diagnostics.  In case you are developing IVDs for Ebola-related, you may refer to WHO guidance in the region.

    Or you may refer to http://regulatorydoctor.us/?attachment_id=18825 

    David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR
    http://www.regulatorydoctor.US
    Phone (Toll-Free): 1-(800) 321-8567
    E-mail:  David@RegulatoryDoctor.US


    Original Message


  • 4.  RE:IVDs in Sierra Leone

    Posted 15-Jul-2015 11:38
    Dear Joy,
    I strongly recommend to get in touch with the WHO / Geneva for countries with limited ressource settings.
    Best

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    Michael Maier
    Partner
    Medidee Services SA
    Chables
    Switzerland
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    Original Message