Medical devices *** divided into three categories, which refers to the scope of the

Medical devices can be divided into three categories based on their risk level and purpose of use. These categories are based on the Classification Catalog of Medical Devices developed by China's National Drug Administration (NMPA).

Class I medical devices: low-risk class. It mainly includes some in vitro, inactive capable medical devices that are in direct contact with the human body, such as masks and general dental materials. Among them, some inactive in vitro diagnostic reagents (such as pregnancy test paper) also belongs to Class I medical devices.

Class II medical devices: medium risk class. It mainly includes certain medical devices that need to be tested and verified, such as electrocardiographs, X-ray machines, infusion pumps and so on. Some active devices, such as certain laser therapy instruments, ultrasound diagnostic instruments also belong to Class II medical devices.

Class III medical devices: high-risk class. It mainly includes medical devices for invasive operations on the human body, such as cardiac pacemakers, artificial joints, brain pacemakers and so on. In addition, some potentially life-threatening medical devices also belong to Class III, such as artificial heart-lung machines, transplant organs and so on.

These three classes of medical devices have corresponding regulations and requirements in registration filing, production supervision, sales licensing and use management. These regulations and requirements are designed to ensure the quality, safety and effectiveness of medical devices, and to protect the rights and interests of patients and healthcare professionals as well as public health and safety.