The second category is medical devices with moderate risks, which need strict control and management to ensure their safety and effectiveness, such as medical suture needles.
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, such as various syringes, infusion sets, pacemakers, artificial heart valves, artificial joints and vascular stents.
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Extended data
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items directly or indirectly used in human body, including required computer software.
Utility is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role.
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; By examining human samples, information can be provided for medical or diagnostic purposes.
References:
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