? The state of medical devices in accordance with the degree of risk of the implementation of the classification management is as follows:
1, a class of medical devices refers to the direct application of the human body, with a low risk of products, such as thermometers, disposable syringes and so on. This type of device can be marketed and sold only by filing and registering. The state has set different regulatory requirements for different categories of medical devices to ensure their quality, safety and effectiveness.
2, Class II medical devices refers to the direct or indirect application to the human body, with a moderate risk of products, such as respiratory machines, cardiac monitors and so on. These devices need to be registered for the record, and through the relevant technical evaluation and clinical trials before they can be marketed.
3, Class III medical devices refers to the direct or indirect application to the human body, with high-risk products, such as artificial heart, orthopedic implant materials. These devices require strict registration and approval, including technical evaluation, clinical trials and review of approval documents, before they can be marketed and sold.
Medical devices are used for the purposes of diagnosis and monitoring, treatment and surgery, support and rehabilitation, prevention and health care
1. Diagnosis and monitoring: medical devices are used to help doctors make an accurate diagnosis of a disease. For example, ECG machines are used to monitor and record the electrical activity of a patient's heart, X-ray machines are used to obtain images of the inside of the body, and glucose meters are used to measure blood sugar levels.
2. Treatment and Surgery: Medical devices are used to treat diseases or perform surgical procedures. For example, pacemakers are used to maintain the normal rhythm of the heart, hemodialysis equipment is used to remove wastes and toxins from the patient's body, and surgical instruments are used to perform surgical procedures.
3, support and rehabilitation: some medical devices are used to support the patient's life function or promote rehabilitation. For example, ventilators are used to provide auxiliary respiratory support, prosthetic and orthopedic devices are used to help people with disabilities to restore mobility, and hearing aids are used to improve hearing.
4, prevention and health care: medical devices can also be used to prevent disease or protect health. For example, oral cleansers are used for oral health care, contraceptive devices are used for contraceptive control, thermometers are used to measure body temperature and so on.