NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft)” today (December 13, 2019). Feedbacks need to be submitted by January 13, 2020. more…

NMPA announced Recall Notices for 16 imported medical devices in November. more…

Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common questions about GMP for medical devices in China. more…