Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

CFDA: Device Pre-Assessment during Supplement Phase Now Available

  • 1.  CFDA: Device Pre-Assessment during Supplement Phase Now Available

    Posted 17-Oct-2018 14:43
    Medical Device Pre-Assessment during Supplement Phase becomes available in China. You will know in advance if you meet the supplemental requirements.

    NMPA (CFDA) issued Notice for Medical Device Pre-Assessment during Supplement Phase on September 12th. The pre-assessment can be requested by manufacturers 2 months before the submission deadline of supplemental materials; CFDA opinion will be given within 20 days after the request. The pre-assessment applies to imported Class II, Class III and domestic Class III medical devices.

    Unlike FDA, CFDA REQUIRES supplements after reviewing your initial registration application. Previously, you can only expect the final decision on your supplements which is a benchmark for the approval of your device/ IVD. As the Pre-Assessment implements, now you can prepare additional materials even if CFDA gives negative comments on your supplements.

    For medical device & IVD registration flowchart, please email info@ChinaMedDevice.com.




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


Related Content