Class I: according to the "Product Quality Law", through routine management, enough to ensure its safety, effectiveness of medical devices (such as sphygmomanometers, hammered diagnostic hammer, oxygen bags, sterilizers, etc.).
The second category: 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 ECG, ultrasound, gastroscope, dental equipment, etc.)
The third category: implanted in the human body, or used for life support, or the complexity of the technical structure of the human body may be potentially hazardous, the safety and efficacy of the medical devices must be strictly controlled. Strictly controlled medical devices. (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 the blood in the body, ultrasound imaging equipment with interventional devices, as implanted in the human body. 7. hyperbaric oxygen chambers, incubators for infants, as life-supporting products, 8. cardiovascular endoscopy. 9. simulated (Auxiliary apparatus).