Regulatory Open Forum

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  • 1.  What is your experience with E-labeling?

    Posted 27-Apr-2016 07:26

    Outside of EU and US, what is your experience with e-labeling?  What do you think is needed to increase acceptance of e-labeling?

     

    Colleen Watson O'Keeffe

    International Regulatory Affairs Manager

    Anaesthesia & Respiratory Disposables

    Vital Signs

     

    75 North Fairway Drive

    Vernon Hills, IL 60061, USA

    * Colleen.OKeeffe@CareFusion.com     

    ( 847 362 9579 

    Fax  312 949-6199

     

    carefusion.com

     



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  • 2.  RE: What is your experience with E-labeling?

    Posted 27-Apr-2016 23:35
    Colleen,

    Countries that I know it is allowed for electronic IFU (eIFU) or e-label(l)ing:

    Australia
    Canada
    Brazil, Colombia, Uruguay, Argentina, etc.
    Turkey

    As a general (safe) practice, the M should make both available. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 3.  RE: What is your experience with E-labeling?

    Posted 28-Apr-2016 04:01
    Colleen:

    Some countries can be added into the list:
    Singapore
    Vietnam
    Malaysia
    Thailand
    Philippines, 
    Taiwan

    Totally agree with Dr. David Lim, for safe practice, both should be available if the cost is not too expensive.

    Cheers,
    Duc Duong-Hong, PhD.



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  • 4.  RE: What is your experience with E-labeling?

    Posted 28-Apr-2016 14:06
    To add one more country:

    New Zealand

    D



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  • 5.  RE: What is your experience with E-labeling?

    Posted 28-Apr-2016 07:12

    Colleen I

    I studied this extensively a day worked on projects to implement where we could, mainly the US. In all of these countries if allowed, it is only acceptable for devices  sold professionally and with many many caveats.

    In Europe  you need to follow the EU  regulation for it. Private message me and I can send materials for you to review. Only certain devices are allowed in Europe and e-labeling is considered a major change to your Quality System. Products with e-IFU only have to be audited by the Notified Body if  new device and your QMS will be audited for processes related to it.

    While I think it is needed, if not reliably obtained and managed, use of e-IFUs may just add additional risk/liability.

    Ginger Cantor
    Centaur  Consulting LLC
    centaurconsultingllc@gmail.com
    715-307-1850




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  • 6.  RE: What is your experience with E-labeling?

    Posted 28-Apr-2016 14:00

    Colleen,

    Not sure about Colombia and Uruguay. However based on my knowledge, these countries do accept eIFU.

    • Australia
    • Belarus
    • Bosnia-Herzegovina
    • Brazil
    • Canada
    • Hong Kong
    • Malaysia
    • Puerto Rico
    • Saudi Arabia
    • Singapore
    • Thailand
    • Turkey
    • United States
    • EU

    Note: Some countries accept eIFU per their regulation however still you should check with local marketing not all hospitals will be able to access it. 

    Additionally, there are restrictions in terms of which products can go eIFU and they may vary from countries to countries. One will need to do a good validation of your IT systems to transition to eIFU. 

    In conclusion, there are many pros to moving to eIFU however cost is not always the one of them. It is important to ensure that customers have access to the IFU. 

    ------------------------------
    [Shiven]
    [Regulatory Affairs]
    [San Francisco] [CA]

    Original Message