China IVD Registration Pitfalls and COVID-19 Test Kit Updates

China IVD Registration Pitfalls and COVID-19 Test Kit Updates

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 from 11:00 a.m. – 12:00 p.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?