The Categories of Medical Devices

 

Today we share the categories of medical devices.

Medical devices are divided into three categories, namely "I, II, and III."

 

Type I refers to medical devices whose safety and effectiveness can be guaranteed by routine management. Generally by the municipal Food and Drug Administration to approve, issued registration certificate. Such as medical scissors, tweezers, ordinary hospital beds, wheelchairs, gauze bandages, etc.

 

Type II refers to medical devices whose safety and effectiveness should be controlled. Generally, the provincial food and drug administration examine and approve issued registration certificates, for example, electronic sphygmomanometer, anti-snoring device, electromagnetic wave therapy instrument, electronic acupoint therapy instrument, and so on.

 

Type III is the implant; Used to support and sustain life; Medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled. For example, syringes, infusion sets, implantation device, etc.

 

Active medical electrical device can be divided into three categories according to the degree of shock protection:  

 

Type B: device with specific protection against electric shocks, such as color ultrasound, electronic sphygmomanometer.

BF type: Type B device with type F isolation application section; for example, physiotherapy department low-frequency electronic pulse treatment device.

CF: Device applied directly to the heart, such as an electrocardiogram machine, ECG monitor.

 

If you have other categories of medical devices, please share them.