Key Changes to Clinical Evaluation in China Webinar

In recent months, China’s regulator (NMPA) has released and updated a series of guidances for the clinical evaluation of medical devices. These changes are subsequent to Order 739, which took effect in June 2021 and mandated a comprehensive set of changes to China’s medical device regulations. This webinar will took a deep dive into the evolving new regulations on clinical evaluation, clinical pathways, decision criteria for clinical trials, establishing equivalence, clinical evaluation reports (CER), and GCP updates.

Learning Objectives

• Grasp the key changes to clinical evaluation following Order 739
• Discover how clinical evidence can be leveraged in more versatile ways
• Become familiar with fast-track approval pathways for cutting-edge innovations and products intended for emergency use
• Discover ways to conduct a clinical evaluation and how to prepare the necessary clinical evaluation report (CER)
• Learn how to demonstrate product equivalence
• Determine when and where a clinical trial is necessary

Registration

This webinar is free for AdvaMed members and government employees. Click here to check if your company is an AdvaMed member.

• AdvaMed Members: $0.00
• AdvaMed Accel Members: $0.00
• Government /Nonprofit: $0.00
• Non-Members: $100.00

Presented by

Featured Speakers

Grace Fu Palma, MBA
CEO, China Med Device, LLC

Grace brings 20+ years of industry experience to the medical device industry. She is the CEO of China Med Device (www.ChinaMedDevice.com) with offices in Beijing and Boston providing turnkey solutions for western medical device/IVD/CDx/combination products companies to enter China with NMPA (CFDA) regulation and CRO services. The company has processed 1,000+ CFDA certificates, 250+ Chinese and western companies’ success. A seasoned bilingual and bi-cultural Medtech executive, she held a variety of marketing, operational and strategic development management positions at both large multinationals and startups. She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart Association (CNAHA) (500+ cardiovascular clinicians) in 2005. A regular speaker at key national and local Medtech meetings, and frequent contributing writer to multiple journals. She grew up in Beijing, China and received a BA from Peking University, China and an MBA from Yale University in New Haven, CT.

Xiaopeng Zhang
New Product Registration, Johnson & Johnson China

Xiaopeng Zhang is responsible for new product registration at Johnson & Johnson China. She has considerable experience in writing clinical evaluation reports and in developing clinical evaluation pathway strategies designed for equivalent device comparison. Before JnJ, she was a medical scientist in Astellas and was responsible for tumor, immune and immunological pre-market products. Zhang holds a doctorate in pathology and pathophysiology from the Xiangya School of Medicine at China’s Central South University.

Webinar Recording