China FDA Draft Guidance on Acceptance of Overseas Clinical Trial Data - Understanding the Potential Impact to Med Device Manufacturers, New Webinar Hosted by Xtalks
TORONTO, April 11, 2018 (Newswire.com) - On October 31, 2017, the China Food and Drug Administration (China FDA) 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 China FDA 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.
Join the live webinar on Friday, April 20, 2018, at 10 a.m. EDT (3 p.m. BST/UK), with guest speaker Dr. Jiechen Yin, NAMSA’s Medical Research Manager and clinical evaluation expert, to gain a better understanding of:
- The new China FDA regulations on medical device registration
- The requirements for acceptance of overseas clinical data
- The potential impact of these regulations on clinical evaluation pathways
For more information or complimentary registration visit: China FDA Draft Guidance on Acceptance of Overseas Clinical Trial Data – Understanding the Potential Impact to Med Device Manufacturers.
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