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China Hainan/GBA Special Policies Enable Unapproved Devices Commercial Launch in Months Instead of Years

June 23 @ 11:00 am 12:00 pm

Two special policy pilot zones in China, the Great Bay Area (GBA) and Hainan, where NMPA unapproved devices, IVDs, and drugs in China can be sold and used in clinical settings. The products can be promoted nationally once used. In addition, the China Hainan Real-World Data/Study (RWD/S) Pilot Program can reduce the China local clinical trial process and time significantly and supplement any overseas clinical evidence deficiencies. This is especially significant for overseas manufacturers with high-value and innovative devices that normally require local China clinical trials by the China NMPA or lacks sufficient clinical evidence to meet China NMPA regulatory requirements. The webinar will provide guidance on the latest updates and the RWD/S program by the Hainan official.

Register NOW for this webinar on Thursday, June 23 from 11:00 AM – 12:00 AM US EST to find out more about how you can benefit from the program to accelerate your China commercialization. Number of attendees are limited.

Topics Covered:

  • The scope/requirements for Hainan and GBA special policy.
  • How to leverage the RWS evidence to supplement the NMPA regular submission
  • The latest practices and case studies of the Hainan commercial pilot and RWS programs
  • How to benefit from the special policies to accelerate your China commercialization with RWD/S
  • The key differences of Hainan and GBA policy