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  • 1.  Challenge registering old product

    Posted 30-Aug-2015 19:52

    Hello,

    I am seeking advice about a situation involving registering an old product.

    Has anyone been put in a situation where the company would like to become more OUS, but have trouble getting R&D to work with them to obtain new data/requirements on an old product that has already been marketed in US and now has to deal with new foreign requirements/regulations?

    R&D focus more on innovation

    How would one take on this situation?

    Any advice would be appreciated.

    Thank you,


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    Zain
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  • 2.  RE: Challenge registering old product

    Posted 31-Aug-2015 01:36

    Hi Zain,

    I think that this is a fairly common occurrence - there is not as much resource available to support legacy products when compared with the resource available/required to continue to develop new, more innovative products.

    My best advice is to outline the potential gaps/risks for gaining market clearance based on current regulatory requirements and current information/documentation available.  Sources may include regulations, e.g. what does the country say is required in a submission, feedback, e.g. questions from previous submissions to the country, etc.  Then you can have an open discussion about the potential risks to gaining market access and allow the business to make an informed decision about how to proceed. 

    Hope this helps,
    Liz

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    Elizabeth Goldstein RAC
    Auckland
    New Zealand
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    Original Message


  • 3.  RE: Challenge registering old product

    Posted 31-Aug-2015 07:41

    Zain,

     

    This is a challenge more and more organizations face as the global regulatory environment becomes more complex and less willing to just "accept" registrations from other markets. You will find that it can even be a challenge for new products, as many R&D organizations want to focus on a single market initially and then move on to the next thing before going back to do additional testing to meet requirements in other markets.

     

    There are a few ways companies try to handle this:

     

    1)      Creation of some type of Continuation or Sustaining Engineering group – these groups do not do "new" products but are tasked with supporting current products

    2)      Including "market expansion" projects in their portfolio planning process – this allows new markets with significant return on investment to be prioritized along with new products, and the ones that rank high enough have project teams and hard goals, just like any other project

    3)      Engaging the commercial teams to identify priorities – and if OUS expansion isn't a priority, then at least everyone is aligned

     

    Obviously, these are not things regulatory can do "alone" but we can be excellent advocates for the need to have these mechanisms and we can help put them into place.

     

    Ginger

     




    Original Message


  • 4.  RE: Challenge registering old product

    Posted 31-Aug-2015 10:40
    Zain,

    Few others have shared their insight.

    From my perspectives, it has to do with business decision.  Based on that, RA can function as "Navigator and Sensor to Signal" or "NSS" as for regulatory issues around business decision and to move forward.

    As a general note, R/D folks enjoy (trying to) be(ing) creative and thus, they are not in the same world sometimes as we, RA professionals, are.

    For consideration by all other firms, it is imperative that firms have a robust regulatory plan/strategy with vision - 2-5-20 years ahead!

    For this matter, I have been providing seminars on the issue for the very same reasons at <https://www.globalcomplianceseminar.com/event/live-seminar-developing-implementing-global-regulatory-plan-strategy/>


    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


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

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 5.  RE: Challenge registering old product

    Posted 31-Aug-2015 14:10

    Hi Zain,

    According to the product, classification, and country you can use different documents. You can use clinical data or you can use post-market data such as complaint data to demonstrate that the device is safe.

    If you have a similar or preadmended product you can use some of the new product information to register the preadmended product.

    Registering products in families is an option too.

    If you products are CE Marked, you can register them with the CE Certificate.

    If you products have been sold in major markets you can use those registrations to register them in other markets.

    Good luck!


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    Aurelia Brownridge
    Regulatory Associate
    San Diego CA
    United States
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    Original Message


  • 6.  RE: Challenge registering old product

    Posted 31-Aug-2015 16:29

    In addition the way I was always able to do this while still in industry was to work with Market & Sales to determine what profit this will bring into the firm within a few business quarters, a year, etc. Partner with them as your champions & R&D will then engage. 

    The suggestion of eventually forming a sustaining engineering group is invaluable. The way regulations and standards are moving and with typical questions that come up for existing products with new indications and or line extensions; this group 
    "pays" fir itself very quickly.

    Regards,

    Fran

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    Frances Akelewicz
    Owner & Principal
    Practical Solutions
    Yardley PA
    United States
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    Original Message


  • 7.  RE: Challenge registering old product

    Posted 01-Sep-2015 00:56

    Thank you all for your input! 

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    Zain 
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    Original Message