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  • 1.  Korea GMP renewal, is all the material provider information necessary?

    This message was posted by a user wishing to remain anonymous
    Posted 12-Oct-2021 10:48
    This message was posted by a user wishing to remain anonymous

    Dear all,

    Our Korean dealer is undergoing their GMP audit and the auditor from Korean authority insist that the device manufacturer should provide the information of manufacturers of "all" the materials. 
    We had checked the regulation and we believe it should be the manufacturer of "major" materials but our dealer only tells us that if we want to protect confidential information from the dealer, contact the auditor directly and never tried the negotiation with the auditor. 

    It would be highly appreciated if you could advise us:
    - if you had similar experience and 
    - how you could have solved it. 

    In our experience, Asian auditor are not negotiable in many cases and we may need to submit something looks like the list of all the material, but the information is confidential and quite bulky.  

    We would like to thank you for your help in advance.


  • 2.  RE: Korea GMP renewal, is all the material provider information necessary?

    This message was posted by a user wishing to remain anonymous
    Posted 17-Oct-2021 20:45
    This message was posted by a user wishing to remain anonymous

    Hello Anonymous,

    I just recently successfully completed a KGMP renewal for one of our devices and I do agree with you that Korea can ask for a lot of detailed information.  Because this particular device is manufactured by a contractor/third party that owns the designs etc, most of the information is confidential and they wouldn't disclose it to us. They instead preferred to interface directly with the reviewer in Korea and provided the requested information. Everything worked out well.

    I hope this helps!


  • 3.  RE: Korea GMP renewal, is all the material provider information necessary?

    This message was posted by a user wishing to remain anonymous
    Posted 18-Oct-2021 15:00
    This message was posted by a user wishing to remain anonymous

    Thank you so much for the advice!
    It is quite helpful to know that the similar situation exits and encouraging to know it could be solved. 
    We will discuss internally about how to deal with the situation.