Legal analysis: The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness. The purpose is to diagnose, prevent, monitor, treat or alleviate diseases; Diagnosis, monitoring, treatment, mitigation or functional compensation of injury; Examination, substitution, adjustment or support of physiological structure or process; Support or sustain life; Pregnancy control; The examination of human samples can provide information for medical or diagnostic purposes.
Legal basis: Article 4 of the Rules for the Classification of Medical Devices According to the degree of risk, medical devices are divided into Class I, Class II and Class III. The risk degree of medical devices should be comprehensively judged according to the expected use of medical devices, through structural characteristics, use forms, use status, contact with human body and other factors.