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  • 1.  China CFDA Issued Ways to Consult its Medtech Reviewers

    Posted 24-Oct-2016 22:57

    Latest CFDA Updates on Ways to Consult with CFDA Medical Device Reviewers

    Medical device companies can communicate directly with China FDA personnel on their submissions and the associated supplement materials.  CFDA has recently published 4 formal ways for the medical device registrants or applicants to consult with its staff in its medical device division.

    1. On-site Consultation: pre-appointment required.

    Time: 9:00-11:30, 13:30-16:30 (Beijing Time), Every Thursday

    1. Online Consultation
    • mainly for relatively simple and easy to answer questions.
    • The technical reviewer can change from online to on-site consultation when necessary
    1. Telephone Consultation
    • Time: 15:30-16:30 (Beijing Time), Every Monday and Wednesday
    1. Q&A for Common Questions Publications
    • The technical review organization would provide unified answers to the common and  repeated questions periodically on its websites.

    Please feel free to contact us if you have further questions info@chinameddevice.com

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


  • 2.  RE: China CFDA Issued Ways to Consult its Medtech Reviewers

    Posted 24-Oct-2016 23:30
    Grace,

    Thank you for sharing great info.

    Would you be able to comment on how differences (between municipal, provincial or State level) are being addressed/resolved in China?

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    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


  • 3.  RE: China CFDA Issued Ways to Consult its Medtech Reviewers

    Posted 25-Oct-2016 11:43

    David,

    State level has different jurisdictions from those at municipal and provincial levels. For imported and domestic class III products,  they must go through state level.  Due to their scope and jurisdictions and local policies, they are not always aligned or use the same decrees.  To make an analogy,  it is kinds of like the U.S. judicial systems: federal court, and state court/local courts. Do you have specific concerns or questions?

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

    Original Message