Business enterprises should fill out the third class of medical devices business license application form to the location of the municipal drug supervision and management department for the record, and submit the license application materials in line with the requirements of the third class of medical devices business license materials. Receive medical device business filing materials of the municipal drug supervision and management department should be field to license the integrity of the reporting materials to verify that meet the prescribed conditions to be licensed, issued to the medical device business license.
Two, analysis
The state has a strict classification of medical devices, and Class III medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, is implanted in the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices.
Third, the characteristics of the medical device license?
The third category of medical devices are 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, more than 200mA X-ray machine, medical high-energy devices, artificial heart-lung machine, internal Fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion, CT equipment.