Three categories.
The first class of medical devices refers to, through routine management is sufficient to ensure its safety, effectiveness of medical devices. According to Article 5 of the Regulations on the Supervision and Administration of Medical Devices issued by the state, the state will implement classified management of medical devices.
Class II medical devices are medical devices whose safety and effectiveness should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry instrument belongs to belong to the second class of medical devices.
The state has a strict classification of medical devices, and class III medical devices is the highest level of medical devices, but also must be strictly controlled medical devices, is implanted in the human body, used to support, maintain life, the human body has a potential danger, its safety, effectiveness must be strictly controlled medical devices.
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Expanded Information
The state of the medical device Classification management according to the degree of risk.
The first category is low-risk, routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
/baike.baidu.com/item/%E4%B8%80%E7%B1%BB%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0 "target="_blank "title="Baidu Encyclopedia - Class I Medical Devices">Baidu Encyclopedia - Class I Medical Devices
/baike.baidu.com/item/%E4%BA%8C%E7%B1%BB%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0/8544474" target="_blank blank "title="Baidu Encyclopedia - Class II Medical Devices">Baidu Encyclopedia - Class II Medical Devices
/baike.baidu.com/item/%E4%B8%89%E7%B1%BB%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0/ 8587703?fr=aladdin "target="_blank "title="Baidu Encyclopedia - Class III Medical Devices">Baidu Encyclopedia - Class III Medical Devices