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CFDA Acceptance of Overseas Clinical Trial Data: Understanding the Impact to Medical Device Manufacturers

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Date/Time

On Demand

Access this On-Demand webinar here.

On October 31, 2018, the China Food and Drug Administration (CFDA) issued, “Amendments to the Regulations on the Supervision and Administration of Medical Devices (Exposure Draft).”  While there are many parallels between the original regulation and this recent Exposure Draft, one of the most significant areas of change pertains to the acceptance of overseas clinical study data and relevant requirements for Chinese medical device registration applicants. What’s more, the CFDA released, “Technical Guidelines for Acceptance of Overseas Clinical Trial Data,” on January 11, 2018 which aims to reduce or avoid repetitive clinical trials so Chinese device manufacturers may accelerate marketing activities.

This NAMSA webinar hosted by XTalks, presented by Dr. Jiechen Yin (NAMSA Medical Research Manager), will provide a better understanding of:

  • – The new CFDA regulations on medical device registration;
  • – The requirements for acceptance of overseas clinical data; and
  • – The potential impact of these regulations on clinical evaluation pathways.
  • *By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com. NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.