Current Regulatory Environment in China

Following State Council Order #650 issued in 2014, CFDA made great deal efforts to complete China medical device regulation system by issuing more regulations, guidance and standards.

Notably two areas of CFDA focuses are shaping the device industry in China. One is device clinical data requirement; the other is the supervision of the whole device development life cycle.

This presentation will discuss CFDA device clinical evaluation report, device GCP, China device clinical trial audit, manufacturer inspections, and device post-market surveillances

Presented by An Liu, NAMSA, China