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.