Although we are not new to medical devices, we do not know much about them, so today we need to give you a refresher course. What is a medical device? Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software. It can be seen that the scope of medical devices is very broad. Its purpose is mainly for the diagnosis, prevention, monitoring, treatment or mitigation of disease and so on. National medical devices in accordance with the degree of risk management: the first category of low risk, the implementation of conventional management can ensure the safety and effectiveness of medical devices. Such as: surgical instruments (knives, scissors, forceps, forceps, hooks), scrapers, medical X-ray film, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc. The second category has a moderate risk, the need for strict control management to ensure their safety and effectiveness of medical devices. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiogram machines, electroencephalography machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasound sterilization equipment, non-absorbable sutures, condoms, etc. The third category has a higher risk, the need to take special measures to strictly control the management to ensure their safety and effectiveness of medical devices. Such as: implantable pacemakers, corneal contact lenses, IOLs, ultrasound tumor focus knife, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, intravascular catheters, etc.. We are more familiar with surgical instruments belong to the first class of medical devices, mercury sphygmomanometer belongs to the second class of medical devices, three types of medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, refers to the implantation of the human body, used to support, maintain life, the human body has the potential risk, the safety and effectiveness of its medical devices must be strictly controlled.