Class I refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices. Generally by the municipal Food and Drug Administration to approve, issue a registration certificate.
Class II refers to its safety, effectiveness should be controlled medical devices. Generally by the provincial Food and Drug Administration to approve the registration certificate issued.
Class III refers to, implanted in the human body: in support of, to maintain life healing: potentially hazardous to the human body, the safety and effectiveness of the base of the gold, the effectiveness of medical devices must be strictly controlled. Generally by the State Food and Drug Administration to approve, issue a registration certificate. For example, China's first medical waterjet "Hazel waterjet", has been approved by the National Innovative Medical Devices, is a Class III medical device, by the State Drug Administration for approval p>