Department of Medical Device Regulation
To organize the formulation and supervise, as per its powers and duties, the implementation of GMP for medical devices, and organize the formulation and guide the implementation of good practices for medical devices distribution and use; to organize and guide the on-site inspections of manufacturing sites, and to investigate and punish serious illegal acts; to organize quality sample inspection and testing and issue quality announcements regularly; to organize the monitoring of adverse events and deal with relevant issues based on laws and regulations.
1) Division of General Affairs
2) Division of Supervision I
3) Division of Supervision II
4) Division of Monitoring, Sampling and Testing