According to the "Regulations on the Supervision and Administration of Medical Devices": the state of medical devices to implement the classification and management of the first category: according to the "Product Quality Law", through the routine management, enough to ensure its safety, effectiveness of medical devices (such as sphygmomanometers, hammers, oxygen bags, sterilizers, etc.). Class II: the product mechanism has been internationally and domestically recognized, technologically mature, its safety and effectiveness must be controlled medical devices (such as electronic thermometer, brain or electrocardiogram, ultrasound, gastroscope, dental equipment, etc.) Class III: implanted in the human body, or used for life support, or the technical structure of the complexity of the human body may be potentially hazardous, the safety and efficacy of medical devices must be strictly controlled. (1. Made of any material, implanted in the human body. 2. Radiotherapy equipment. 3. Respiratory anesthesia equipment. 4. Extracorporeal circulation equipment. 5. X-ray, CT, ultrasound, positronic. 6. Contact with in vivo blood, ultrasound imaging equipment with interventional apparatus, deemed to be implanted in the human body. 7. Hyperbaric oxygen chambers, incubators for infants, deemed to be a life-supporting product, 8. Cardiovascular endoscopes. 9. Simulative (Assistive devices).
Ozida medical equipment consulting organization