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  • 1.  CFDA Medical Device testing for PMS

    Posted 19-May-2017 15:26
    My company has received a request from CFDA for product samples in order to perform post market testing on registered devices. We received registration approval in China following in-country testing to establish compliance to the relevant standards in effect at that time as defined in the Product Standard for the product being approved. My question is when the product samples are tested as part of post market surveillance (PMS) by CFDA, are they expected to be in compliance to any newly updated relevant standards, or is it to ensure they are compliant to the standards which were current at the time the products were registered? If anyone has experience with this PMS testing done by CFDA I would appreciate your feedback and any CFDA references you could provide. Thank you in advance!

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    Andrea Curria
    Regulatory Affairs Specialist
    Medtronic
    Mansfield, MA
    United States
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  • 2.  RE: CFDA Medical Device testing for PMS

    Posted 20-May-2017 06:43

    The answer is depending whether you are in the renewal application phase or you are being simply asked for post market compliance.  The latter is very rare and you are not required to test to new standard.  Big companies like Medtronic, J&J etc have been inspected on site by the CFDA officers especially for class III devices.  So simply being asked out of the blue without any context is rare.

    You are Not obligated to comply with the new standards until you start to apply to renew your device.  Unlike FDA in the U.S., very 5 years for class II and III, you are required to renew your registration.  The renewal should start at least 12 month before your current registration expires to ensure the time needed to comply with the new regulations.  The renewal phase needs to comply with the new standards.  There is a lot of ART in this phase!  If you need any help, please contact me gpalma@ChinaMedDevice.com  We have been in medtech CFDA for 10 + years.



    ------------------------------
    Grace Fu Palma
    China Med Device, LLC
    MA, U.S.
    gpalma@chinameddevice.com
    978-390-4453
    www.chinameddevice.com
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    Original Message


  • 3.  RE: CFDA Medical Device testing for PMS

    Posted 20-May-2017 08:41
    Andrea,

    The CFDA inspection guide sets forth nine areas of postmarket enforcement measures.  One of nice areas involves targeted monitoring and product sampling. 

    Your firm and the product are targeted.  :-)

    During registered period, the request should be interpreted "to ensure they are compliant to the standards which were current at the time the products were registered..."

    Thank you.

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

    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


  • 4.  RE: CFDA Medical Device testing for PMS

    Posted 23-May-2017 10:49
    Thanks you both for your replies, very helpful!

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    Andrea Curria
    Regulatory Affairs Specialist
    Cumberland RI
    United States
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    Original Message


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