While LDTs have been used in the US for over 30 years, they have not been utilized in China. In 2021, China issued its first LDT regulations, but they were vague and led to uncertainty. Recently, China has issued some new regulations including the national LDT Pilot Regulations and Shanghai LDT Pilot Regulations. These pilot programs will be the foundation for future Chinese LDT regulations.
Only ten hospitals and no independent clinical labs are being utilized for these pilot LDT studies. Both pilots have specific requirements. For example, at each pilot hospital, there is a person in charge of which reagents will be used. In addition, each site must set up its own ethics committee, the review process, and QMS. Reagents used in these pilots will need to submit information to the NMPA and NHC to be used, and they will need to be significantly different than existing IVDs already approved in China.