Drugdu.com expert's response:

Medical devices are typically categorized into three classes as follows:

Class I Medical Devices: These devices pose a low level of risk and can ensure their safety and effectiveness through routine management. They are generally the basic and relatively safe medical tools commonly used in daily medical practice.

Class II Medical Devices: This class of devices carries a moderate level of risk and requires stricter management measures to ensure their safety and effectiveness. They may involve certain usage risks, necessitating specialized personnel for supervision and control.

Class III Medical Devices: These devices pose a high level of risk and necessitate the implementation of exceptionally stringent control measures to guarantee their safety and effectiveness. They are predominantly used for sustaining patient life, with many requiring entry into the human body, thereby harboring heightened risks that necessitate more rigorous supervision and monitoring.

The classification of medical devices into these three categories is primarily based on factors such as their risk level, mode of use (e.g., whether they contact or enter the human body), and structural characteristics. This categorization facilitates targeted management and regulation of medical devices with varying levels of risk.