What are the categories of medical device products?

Class I medical devices refer to medical devices that are sufficient to ensure their safety and effectiveness through routine management.

Class II medical devices refer to medical devices whose safety and effectiveness should be controlled.

Class III medical devices refer to those implanted in the human body; used to support and sustain life; Medical devices that are potentially dangerous to the human body and must be strictly controlled for their safety and effectiveness.

Beijing Zhongxing Famous Industry Science and Technology Development **** (professional service medical devices).

The state implements classified management of medical devices according to the degree of risk.

Medical devices are divided into 3 categories:The first type of medical devices with a low degree of risk and routine management can ensure their safety and effectiveness.

Such as stethoscopes, gauze bandages, surgical gowns, surgical caps, etc.

The second category is a medical device with a medium risk and requires strict control and management to ensure its safety and effectiveness.

Such as thermometers, blood pressure monitors, hearing aids, acupuncture needles, etc., medical masks also belong to the second category.

The third category is a medical device with a higher risk and implanted in the human body, which requires special measures to strictly control and manage it to ensure its safety and effectiveness. Such as implantable pacemakers, etc.

The classification principles of medical devices in various countries are generally determined according to their risk level, with the lowest category 1 and the highest order of class in order.

China's "Rules for the Classification of Medical Devices (Decree No. 15)" stipulates that:

Article 4 To determine the classification of medical devices, a comprehensive judgment should be made based on the structural characteristics of the medical device, the form of use of the medical device and the use status of the medical device.

The specific determination of the classification of medical devices can be carried out in accordance with the "Medical Device Classification Judgment Table" (see annex).

Article 5 The basis for the classification and judgment of medical devices.

1) Structural characteristics of medical devices.

The structural characteristics of medical devices are divided into: active medical devices and passive medical devices.

2) The form of use of medical devices.

According to the different intended purposes, medical devices are classified into certain forms of use. Where:

1.The use of passive devices includes: liquid medicine delivery and preservation devices; change of blood and body fluid apparatus; medical dressings; surgical instruments; reuse of surgical instruments; Disposable sterile instruments; implantable devices; contraceptive and family planning devices; disinfection and cleaning equipment; Nursing devices, in vitro diagnostic reagents, other passive contact or passive auxiliary devices, etc.

2.The forms of use of active devices include: energy ** devices; diagnostic monitoring devices; devices for transporting body fluids; ionizing radiation devices; laboratory instruments and equipment, medical disinfection equipment; Other active devices or active auxiliary equipment, etc.

3) The use status of medical devices.

According to the possibility of damage to the human body and the impact on the medical effect in use, the use of medical devices can be divided into contact or entry into human devices and non-contact human devices, which can be divided into:

1.Contact with or into human devices.

1) The time limit of use is divided into: temporary use; short-term use; Long-term use.

2) The parts that come into contact with the human body are divided into: ** or cavities; trauma or internal tissues; Circulatory system or central nervous system.

3) The degree of damage caused by the loss of control of active devices is divided into: minor injury; Damage; Serious injuries.

2.Non-contact human devices.

The degree of impact on medical outcomes is divided into: basically no impact; There are indirect effects; has an important impact.

Specifically, you can go to the State Food and Drug Administration** to inquire about the level of the specific category.

The state implements classified management of medical devices according to the degree of risk.

The first type is medical devices with a low degree of risk, and the implementation of routine management can ensure their safety and effectiveness.

The second category is medical devices that have a medium risk and need to be strictly controlled and managed to ensure their safety and effectiveness.

The third category is medical devices with high risk and need to take special measures to strictly control and manage them to ensure their safety and effectiveness.

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used in the human body, including the required computer software.

The effect is mainly obtained by physical means, not pharmacological, immunological or metabolic methods, or although these methods are involved, they only play an auxiliary role.

The purpose is to diagnose, prevent, monitor, or alleviate the disease; diagnosis, monitoring, mitigation or functional compensation of injuries; testing, substitution, regulation or support of physiological structures or processes; life support or maintenance; pregnancy control; Samples from the human body are examined to provide information for medical or diagnostic purposes.