Medical devices refer to instruments, equipment, appliances, materials or other articles used for human body alone or in combination, including required software. The purpose of using these articles is to diagnose, treat, monitor, alleviate or compensate human diseases and disabilities, and to study pregnancy control, anatomy or physiological processes. Their effects on human body are not obtained by pharmacological, immunological or metabolic means, but they may participate in it and play a certain auxiliary role.

Classification catalogue of medical devices

According to the Regulations on the Administration of Medical Devices, medical devices in China are divided into three categories:

The first category: medical devices that can ensure their safety and effectiveness through routine management, such as common scalpels, scissors, dressings, etc.

Category II: Medical devices whose safety and effectiveness should be controlled, such as medical suture needles.

The third category: medical devices implanted in human body to support and maintain life are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled, such as various syringes, infusion sets, pacemakers, artificial heart valves, artificial joints and vascular stents.

Medical devices: /ylqx/