China FDA Guidance on Acceptance of Overseas Clinical Trial Data –Understanding the Potential Impact to Med Device Manufacturers

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.

This NAMSA webinar, presented by Dr. Jiechen Yin (NAMSA Medical Research Manager), will provide 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

Speaker

Jiechen Yin, PhD, Medical Research Manager

Dr. Jiechen Yin serves as NAMSA’s Medical Research Manager and is responsible for NAMSA’s clinical evaluation service offering in China. Dr. Yin has vast experience in the development of clinical evaluation strategies, Clinical Evaluation Reports (CERs) and clinical trial protocols. She has successfully managed numerous CERs following China FDA’s “Technical Guidelines for Clinical Evaluation on Medical Devices (2015)” and “MEDDEV 2.7.1. Revision 4 (2016)” for cardiovascular, radiology, robotic surgery, hearing aid, orthopedic, and wound healing devices. Prior to joining NAMSA, Dr. Yin conducted work in scientific research and medical device R&D. She has published multiple high-impact scientific journal articles as first author, and is a holder of multiple patents.

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