Medical radiation protection spray products in accordance with the second class of medical device management, the State Drug Administration official website information shows that our country according to the safety of medical equipment products on medical devices for classification and management. Classification catalog by the State Food and Drug Administration based on medical device classification rules:
The first class is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices. Such as: surgical instruments (knife, scissors, pliers, tweezers, hooks), scraping board, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze, bandages, drainage bags and so on.
The second category is a moderate risk, need to strictly control the management to ensure its safety and effectiveness of medical devices. Such as medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalograms, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound sterilization equipment, non-absorbable sutures.
The third category is a higher risk, need to take special measures to strictly control the management of medical devices to ensure their safety and effectiveness. Such as: implantable cardiac pacemakers, corneal contact lenses, artificial crystals, ultrasound tumor focusing knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machine, dental implantable materials, medical absorbable sutures, intravascular catheters and so on.