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  • 1.  Taiwan labels in traditional Chinese

    Posted 05-May-2021 07:50

    Hi,

     

    We are informed by the Taiwanese distributor that the medical devices for supply to Taiwan should labelled in traditional Chinese. Is this information correct ?

     

     

    Thanks & Regards,

    signature_1537400070

    Rashmi Pillay

    Regulatory Affairs Manager

    Ellex – Lumibird Medical group

    3-4 Second Ave, Mawson Lakes SA 5095
    Tel. +61 8 7074 8105

    Email rpillay@ellex.com

     

     

     

     

     

     

     

     

     

     

     

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.

     



  • 2.  RE: Taiwan labels in traditional Chinese

    Posted 06-May-2021 06:57
    Hi Rashmi 
    My distributor informed me about this as well. He now tries to find out if he would be allowed to stick Chinese labels on our products, or if the lables have to be attached before entering Taiwan.
    Regards Oscar

    ------------------------------
    Oscar Banz
    RA & VIG Manager
    Thommen Medical AG
    Grenchen
    Switzerland
    ------------------------------

    Original Message


  • 3.  RE: Taiwan labels in traditional Chinese

    Posted 06-May-2021 11:00
    Hi Rashmi,

    Our distributor informed us of this change as well. We followed up with TFDA and the compliance date was this week I believe, however I have heard that only the IFU needs to be translated in Traditional Chinese, if your product does not have an IFU then the label needs Traditional Chinese. I have also heard that they are allowing you to send a soft copy translated IFU to TFDA/customs in the meantime while you update labeling/IFU.

    Thanks


    ------------------------------
    Adam Black
    Regulatory Affairs Specialist
    Ultradent Products Inc.
    South Jordan UT
    United States
    ------------------------------

    Original Message


  • 4.  RE: Taiwan labels in traditional Chinese

    Posted 06-May-2021 18:11

    Thanks Adam!, that's really helpful to know that the IFU translation is sufficient .

     

     

    Thanks & Regards,

    signature_1537400070

    Rashmi Pillay

    Regulatory Affairs Manager

    Ellex – Lumibird Medical group

    3-4 Second Ave, Mawson Lakes SA 5095
    Tel. +61 8 7074 8105

    Email rpillay@ellex.com

     

     

     

     

     

     

     

     

     

     

     

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.

     




    Original Message


  • 5.  RE: Taiwan labels in traditional Chinese

    Posted 06-May-2021 14:15
    Edited by Emilia Spallanzani 06-May-2021 14:16

    Dear Rashmi,

    From my experience I can confirm this, labeling (IFU+label) for medical devices in Taiwan must be in traditional Chinese.

    Regards,



    ------------------------------
    Emilia Spallanzani
    QA&RA Manager
    Paul Hartmann AG - ENTERPRISE
    Heidenheim
    Germany
    ------------------------------

    Original Message


  • 6.  RE: Taiwan labels in traditional Chinese

    This message was posted by a user wishing to remain anonymous
    Posted 07-May-2021 08:33
    This message was posted by a user wishing to remain anonymous

    Dear All,

    I suppose there are some items to be clarified. 
    1. Are both the labels and IFU should be written in the traditional Chinese (in addition, for both OTC and professional use)?
    2. Could they be added in Taiwan or should be included when the product arrives at the custom? 
    In addition, as there had been major regulatory change from 1st of May in Taiwan:
    3. Had any new requirement started from this month?

    I found that EMERGO introduced a lot of new regulations but I don't know if the answers are included in them or not. 
    https://www.emergobyul.com/blog/2021/05/taiwan-update-classification-scheme-final-fee-schedule-post-market-surveillance?utm_source=RADAR&utm_medium=Email&utm_campaign=Email-RADAR

    Sorry that I don't have the answer to questions but I also believe the label and IFU should be in the traditional Chinese, though, IFU could be added by the dealer. 

    Original Message


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