If there is no Class III medical device license, many products can not be sold, such as in vitro diagnostic reagents belong to the Class III medical devices
The Class III devices are these: used for implantation in the human body or to support the life-sustaining, potentially hazardous to the human body, the safety and effectiveness of which must be strictly controlled medical devices. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, patient invasive monitoring system, IOLs, invasive endoscopy, ultrasound scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpel, microwave therapy, medical nuclear magnetic **** vibration imaging equipment, X-ray therapeutic equipment, X-ray machine above 200mA, medical high-energy equipment, artificial heart-lung machine, internal fixation devices, artificial heart valves, artificial kidney, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion, CT equipment.
Class III medical devices, as the most dangerous class in the current classification of medical devices, are strictly supervised and managed by the relevant departments
Category III medical devices have the highest risk.