China Medical Device Registration Clinical Pathways Latest Updates

Date: Wednesday, June 6, 2024
Time: 8am – 9pm PT
Audience: Regulatory and clinical professionals in medical device industry
Platform: Zoom

Struggling with determining the regulatory pathways for your device in China? Which pathway needs clinical evidence? Is clinical trial needed to support your device registration in China?

This webinar provides an overview of the critical elements of China’s registration and clinical pathways, focusing on the China regulatory and clinical framework and finds the least burdensome pathway with the latest China NMPA (National Medical Products Administration) updates.
Submit your questions after registration and have them answered at the event!

Learning Objectives:

1. Overview of key pathways for medical device and IVD registration
2. Explore the clinical evaluation requirement for product registration in China
3. Learn about the key requirements and criteria to determine the different clinical pathways
4. Understand the role of RWE in clinical evidence to support product registration

Register now to secure your spot and empower your team for success!

About the Speakers:

Magda Michna, Ph.D., Chief Clinical, Regulatory and Medical Affairs Officer at STAAR Surgical Company

Grace spearheads China Med Device, a sector of Accel Groups, streamlining market access for medical device firms. With three decades’ experience in global business strategy, regulatory affairs, and clinical trials, she’s bilingual and a recognized expert in China and US MedTech. She’s also founded the Chinese American Heart Association, strengthening connections between clinical communities in the US and China. A member of prominent physician communities like ANACP and CAP, Grace is deeply entrenched in clinical networks bridging the US and China. Raised in Beijing, she holds a BA/BS from Peking University and an MBA from Yale University.

Yan Sheng, PhD, Project Manager at China Med Device, LLC/Accel Groups

Yan has extensive experience in the life science industry, having worked in both the United States and China. With over four years as a project manager at China Med Device/Accel Groups, her expertise extends to a diverse range of areas, including IVD and CDx products, combination products, as well as medical devices such as implants, aesthetics devices, etc. Yan holds a PhD degree in Pharmaceutical Sciences and has a rich history of working with cutting-edge technologies in the realms of both chemistry and microbiology prior to her entry into the life science industry.

Free for Member
$20 for Nonmember

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