Medical device product registration management: the product classification principles, namely: Class I refers to the routine management is sufficient to ensure the safety and effectiveness; Class II refers to the product mechanism has been internationally and domestically recognized, technically mature, safety and effectiveness must be controlled; Class III refers to the implantation of the human body, or used for life support, or the complexity of the technical structure of the human body may be potentially dangerous, safety and effectiveness must be strictly controlled;
So this device must be Class III
So this device must be Class III
This device is Class III
This device is Class III
. safety, effectiveness must be strictly controlled;
So this device must be the third category