Key Changes to Clinical Evaluation in China Webinar

November 18, 2021
10:30 AM – 11:30 AM

Upcoming Events

Get the latest on NMPA’s updated guidance for the clinical evaluation of medical devices

Key Changes to Clinical Evaluation in China Webinar

November 18, 2021
10:30 AM – 11:30 AM

Upcoming Events

  1. Overview
  2. Speakers
  3. Recording

Key Changes to Clinical Evaluation in China Webinar

November 18, 2021
10:30 AM – 11:30 AM

Upcoming Events

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


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

China Med Device Logo

Featured Speakers

Grace Palma Headshot

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 ( 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 headshot

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

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