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  • 1.  Korean registration transfer: Is it possible?

    This message was posted by a user wishing to remain anonymous
    Posted 16 days ago
    This message was posted by a user wishing to remain anonymous

    Dear Professionals,

    Could you advise us the following two points about the Korean registration?

    Situation:

    We are a medical device manufacturer and has class 2 registrations in Korea owned by our dealer.

    As we would like to change the sales channel, we want to change the registration folder to the professional service provider if the dealer will agree with it.

    Question:

    1.  Is it possible to change the GMP certificate folder?
          I suppose the GMP is connected to the registration holder and not us (overseas manufacturer) in Korea and is not possible to transfer but could you clarify?
    2. Is it possible to transfer the medical device certificate from our dealer to Korean registration holder service provider?

    Thank you in advance for your support!



  • 2.  RE: Korean registration transfer: Is it possible?

    Posted 13 days ago

    Anon,

    Yes, it is possible though depending on your situation may take a few weeks or take a few months because a new registration might be required.  The GMP certificate or Korea Good Manufacturing Practice (K-GMP) certificate should be assigned to the actual Manufacturer or who is responsible for the actual manufacturing of the device (this is based on ISO 13485).  Because depending on the device classification this may require a QMS audit or inspection performed by a third party organisation (usually for Class II devices) or MFDS themselves.  While the registration may be in the name of the South Korea License Holder (KLH), the K-GMP should identify the actual manufacturer.  The licenses/product registration can be transferred from one entity to another, again it depends on the situation and how the registration was originally made.  We always recommend in-country local representatives be represented by an independent entity because when assigning this to distributors or dealers, this can be challenging especially if the distributor or dealer is not cooperative.  You should contact a local in-country expert or consulting firm to assist with your specific needs.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------



  • 3.  RE: Korean registration transfer: Is it possible?

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    Dear Richard,

    Thank you so much for the very valuable advice!

    May I confirm if my understanding is correct?

    About the K-GMP

    • In our case, it was handled by our South Korea License Holder (KLH) and we have never seen it. 
    • Do you mean that the K-GMP certificate should identify the manufacturer of each device, thus, it should be able to transfer from the current KLH to the other entity if the KLH agree with it?

    Thank you so much for your support!




  • 4.  RE: Korean registration transfer: Is it possible?

    Posted 12 days ago

    Anon,

    Well to be honest, it is a bit shocking you have never seen this.  Indeed the K-GMP certificate identifies the manufacturer of the device - so you should request this from your current KLH to understand what has been stated.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Principal Strategy Consultant
    NAMSA
    ------------------------------



  • 5.  RE: Korean registration transfer: Is it possible?

    This message was posted by a user wishing to remain anonymous
    Posted 11 days ago
    This message was posted by a user wishing to remain anonymous

    Dear Richard,

    Thank you so much for the information.
    Actually, it is a bit difficult for us to communicate with the Korean representative efficiently now. So, it would be advantageous if we can transfer the registration to non-dealer agent. 

    Your advices are so helpful and thank you so much!