This webinar will cover clinical pathways to support NMPA (CFDA) medical device/IVD regulatory submission or post market surveillance. In addition, the traditional clinical evaluation report which oversees clinical data acceptance, clinical trial and real world data/evidence will be discussed. We will also cover key considerations on the feasibility and justification of overseas clinical data acceptance.
Finally, attendees will learn about the emerging use of Real World Data (RWD) being piloted in HaiNan, China – a cost-effective and less time-consuming alternative to the traditional clinical trial. Overseas manufacturers can obtain approval for the RWD pilot program through the Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval, significantly shortening the time to begin selling devices in China. Don't miss out on the opportunity to learn more about this new policy!
This informative webinar will provide you with:
- Key factors for China clinical strategy and pathways to support submission
- Key differences in China CER and EU CER
- Updates on the Real World Data pilot program to reduce clinical trial cost and time
Grace Fu Palma, CEO of China Med Device, LLC
Grace brings 20+ years of industry experience to the medical device industry. She has extensive management experience in marketing, business development, partnerships, and international commercialization from large multinational corporations (Hewlett Packard Medical Products Group, Phillips Healthcare) to start-ups (Teratech Corp). As the founder of the Chinese American Heart Association in 2005, she built the 500-member leading cardiovascular clinicians and scientists’ society with Chinese origins. The combination of cross-cultural mentality and deep Sino-U.S. medtech knowledge and professional experience in China and the United States has enabled CMD to help more than 50 medtech companies with their China entry and growth since its inception. Grace is originally from Beijing, China and graduated with a Bachelor’s degree from Beijing University and an MBA from Yale University.