The state has classified medical devices according to the level of risk.
Medical devices are divided into 3 categories:
The first category of low-risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
such as stethoscopes, gauze bandages, surgical gowns, surgical caps.
The second category has a moderate risk, need to strictly control the management to ensure its safety, effective medical devices.
Such as thermometers, sphygmomanometers, hearing aids, acupuncture needles, etc. Medical masks also belong to the second category.
The third category has a higher risk, implanted in the human body, need to take special measures to strictly control the management to ensure its safety, effective medical devices. Such as implantable cardiac pacemakers.