Categorization of medical devices:
1. Class I. Through routine management is sufficient to ensure the safety and effectiveness of medical devices. Such as most of the surgical instruments, stethoscopes, medical X-ray film, medical X-ray protection, automatic electrophoresis, medical centrifuges, slicers, dental chairs, boiling sterilizers, gauze bandages, band-aids, surgical gowns, surgical caps, masks, urine collection bags, etc.;
2, Class II. The safety and effectiveness of medical devices should be controlled. Such as thermometers, sphygmomanometers, cardiac diagnostic instruments, optical endoscopes, dental comprehensive treatment instrument, medical cotton wool;
3, Category III. Implanted in the human body; used to support life-sustaining; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Such as implantable cardiac pacemakers medical education|web editing, extracorporeal shock wave lithotriptic machine, invasive endoscopy, ultrasound scalpel, laser surgical equipment, blood transfusion, single-use infusion set, single-use sterile syringes, CT equipment, etc..
Legal basis: "supervision and management of medical devices regulations" Article 62
Medical device registrants, filers should establish medical device adverse event monitoring system, with its products appropriate adverse event monitoring organizations and personnel, its products to actively carry out the monitoring of adverse events, and in accordance with the State Council drug supervision and management department. The provisions of the department, to the medical device adverse event monitoring technical institutions to report the investigation, analysis, evaluation, product risk control.