NMPA Gives Full Support To China Real World Data Application Pilot Projects


On April 22, 2022, NMPA published a Communication Procedure for Medical Device Real World Data Application Projects in Hainan Boao Lecheng Medical Tourism Pilot Zone. As per this Procedure, NMPA will enhance the guide on medical device pilot program in Hainan to help apply RWD for China registration.

Hainan Medical Tourism Pilot Zone

Urgent Use Policy & RWD

What Products are Qualified ?


Hainan Pilot Zone Benefits: Commercial & Regulatory​

Real World Data Application​

NOTE: Currently, real world data cannot be used as sole clinical evidence; however, it can be used to support product registration as a supplement to existing evidence.

Hainan Real World Study Program (RWD Pilot ProgramFast Track Program)

NMPA Approval Examples with RWD​

Boston Scientific


BradyKnows is managing eight real world studies now in Hainan to help overseas manufactures use RWD for supporting China registration. Pls feel free to reach out to us for any questions in China RWD via info@bradyknowsmedical.com