The animal experiment mainly provides evidence for the finalization of product design, provides the evidence for the medical device to enter the clinical research stage, and realizes the protection to the clinical subject.
If new mechanism, working principle, structure design, application methods (such as operation), performance improving is adopted, the administrative counterparts should focus on the relevant risk assessment of innovation point, and make verification and/ or validation on the efficacy of risk control methods, therefore to conform whether to carry on the animal experiment referring to the risk management principles.
For example, carbon dioxide laser therapy equipment adopts
new structural design to improve performance, or new functions (such as lattice scanning) for new clinical purposes. When bench performance test research is not sufficient to determine the basic safety of the product, animal experiments should be carried out before clinical trials.
Animal experiments do not have to make control group.
