The animal experiment mainly provides evidence for thefinalization of product design, provides the evidence for the medicaldevice to enter the clinical research stage, and realizes the protectionto the clinical subject.
If new mechanism,working principle, structure design,application methods (such as operation), performance improving isadopted, the administrative counterparts should focus on the relevantrisk assessment of innovation point, and make verification and/or validation on the efficacy of risk control methods, therefore toconform whether to carry on the animal experiment referring to therisk management principles.
For example,carbon dioxide laser therapy equipment adoptsnew structural design to improve performance, or new functions(such as lattice scanning) for new clinical purposes. When benchperformance test research is not sufficient to determine the basicsafety of the product, animal experiments should be carried outbefore clinical trials.

Animal experiments do not have to make control group.