Recently, Shanghai MicoPort Medical (Group) Co., Ltd. (hereinafter referred as MicroPort) received re-registration certificate issued by the State Food and Drug Administration (SFDA Category II, 2013 No. 2540303) for Radial Artery Hemostasis set. The validity period is through Februa
ry 7, 2017.
Radial Artery Hemostasis set is independently developed and manufactured by MicroPort. It is mainly used to stop bleeding after the needle puncture in a minimally invasive surgery such as coronary angiography or percutaneous coronary interventional procedures. The product received its first registration in January 2010. Due to the category change in SFDA for certain products, Radial Artery Hemostasis set has been upgraded to the category II, therefore the additional clinical data pertaining to categorical change was required for receiving re-registration certificate. The upgrade represents the increasing requirement of product manufacturing control, quality management and additional clinical applications for MicroPort's Radial Artery Hemostasis set.