Class I medical devices: low risk. It mainly includes some in vitro, inactive and direct contact with human body medical devices, such as masks and general dental materials. Among them, some inactive in vitro diagnostic reagents (such as pregnancy preparation test paper) also belong to the first class of medical devices.
Category II medical devices: medium risk. It mainly includes some medical devices that need to be tested and verified, such as electrocardiograph, X-ray machine, infusion pump, etc. Some active instruments, such as laser therapeutic instruments and ultrasonic diagnostic instruments, also belong to the second class of medical instruments.
The third kind of medical devices: high risk. It mainly includes medical devices that perform invasive operations on the human body, such as cardiac pacemakers, artificial joints and brain pacemakers. In addition, some potentially life-threatening medical devices also belong to the third category, such as artificial heart-lung machines and organ transplants.
These three types of medical devices have corresponding regulations and requirements in registration, production supervision, sales license and use management. These regulations and requirements are aimed at ensuring the quality, safety and effectiveness of medical devices, safeguarding the rights and interests of patients and medical personnel, and public health and safety.