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China IVD Registration Pitfalls and COVID-19 Test Kit Updates Webinar

July 23, 2020
Global
Webinar

The China IVD market has seen record growth recently and will continue to be an important market with the growing threat of cancer and COVID-19. Join us on Thursday, July 23 at 11 a.m. EDT for the free webinar: China IVD Registration Pitfalls and COVID-19 Test Kit Updates. Attendees will receive comprehensive IVD guidance based on NMPA's public training programs, as well as the latest guidance relating to COVID-19 test kits. Don't miss this opportunity to learn more about NMPA's requirements for IVD product registration! 

Topics Covered:

  • What are the key regulations for IVD/CDx in China?
  • How to determine the registration units when applying for NMPA approval?
  • How to prepare the registration documents to meet the specific requirements described in regulation guidelines?
  • What are the pitfalls in the registration process?
  • What are the key clinical pathways?
  • What is the current status of NMPA approved COVID-19 detection kits?
  • What are the clinical trial requirements on COVID-19 detection kits?


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 entier 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 bicultural 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.

 

Yan Sheng, PhD
Project Manager, China Med Device
Yan Sheng, PhD, is the project manager of China Med Device. She grew up in China with many years of working experience in the life science industry in both US and China. She received her bachelor’s degree in pharmaceutical science in China and PhD at Oregon State University in the US. Her PhD studies focused on natural products discovery from microbial world. With more than 6 years’ experience in academic field, she is familiar with cutting edge technologies in both chemistry and microbiology fields.

 

Qianqian Zhu
Director, International Regulatory Affairs, Immucor, Inc
Qianqian serves as the International Regulatory Affairs manager at Immucor, Inc, a multinational medical device manufacturer of transfusion and transplantation diagnostic products. Qianqian was an attorney in China prior to moving to Dubai and then the US. She holds a Master of Business Administration, Master of Laws, a graduate certificate of Regulatory Affairs from The University of Georgia and is currently finishing her Master's in Regulatory Affairs. Qianqian was RAC Global certified in 2016.