Question：Is it acceptable to make cross reference to the research documents of the transcatheter mitral valve clamp if the transcatheter tricuspid valve clamp is from the same company and with the same design, materials and manufacturing process as those of the transcatheter mitral valve clamp?
Answer：You can do so after demonstrating their subsequent equivalence. The applicant should take consideration of the application site, anatomical structure characteristics and hemodynamic effects. Supplement some research information when necessary.
Question: Is it necessary to set “uniformity” as a performance indicator of the control kit and calibration standard when preparing the IVD technical requirement?
Answer：Uniformity is a must-have performance indicator for those individually registered control kit, or calibration standard, or IVD with control kit and/or calibration standard. Other performance indicators are decided by the applicant according to the specific situation.