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

Medical Device, Medical Device Clinical Trials, Medical Device Safety and Regulation,
  • April 20, 2018

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

Speakers

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.

Who Should Attend?

Department Heads/Senior Professionals working within:

  • R&D
  • Regulatory Affairs
  • Outsourcing

What You Will Learn

  • 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

Xtalks Partners

NAMSA

NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying its unique combination of disciplines — consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality — to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.

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