What is a medical device
Medical devices refer to instruments, equipment, appliances, materials or other items used alone or in combination on the human body, including the required software. The purpose of using these items is to diagnose, treat, monitor, alleviate or compensate for human diseases and disabilities, as well as to study pregnancy control, anatomy or physiological processes, etc. Their effects on the human body are not obtained by pharmacological, immunological or metabolic means. But these means may be involved and play a certain supporting role.
Medical Device Classification Catalog
According to the "Medical Device Management Regulations", my country divides medical devices into three categories:
Category 1: Through routine management Medical devices that are sufficient to ensure their safety and effectiveness, such as ordinary surgical knives, scissors, dressings, etc.
Category 2: Medical devices whose safety and effectiveness should be controlled, such as medical suture needles, etc.
Category 3: Medical devices that are implanted into the human body and used to support and maintain life. They are potentially dangerous to the human body and their safety and effectiveness must be strictly controlled, such as various syringes, infusion sets, Pacemakers, artificial heart valves, artificial joints, vascular stents, etc.
Medical equipment:/ylqx/