Up to now, the China Food and Drug Administration (CFDA) has totally approved 178,451 medical device products to the market and has established classifications for approximately 3,100 different generic types of medical devices. These medical devices are classified into three classes based on the risk level to ensure the safety and effectiveness of the device, that is, the risk the device poses to the patient and/or the user is the major factor in the class it is assigned. The three classes and the risk level which apply to them are defined as follows:
- Class Ⅰ. Medical device with low risk, the safety and effectiveness of the device can be ensured through general controls.
- Class Ⅱ. Medical device with medium risk, strict controls are required to ensure the safety and effectiveness of the device.
- Class Ⅲ. Medical device with great risk, special controls are required to ensure the safety and effectiveness of the device.
The risk level of using medical device is comprehensively evaluated by the intended use, the structural characteristics of the device, the indication for use and in combination with requirements for the supervision and administration of the device.