Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including required computer software.
The utility is mainly obtained through physical methods, not through pharmacological, immunological or metabolic methods, or although these methods are involved, they only play an auxiliary role.
The purpose is the diagnosis, prevention, monitoring, treatment or relief of disease; the diagnosis, monitoring, treatment, relief or functional compensation of injury; the examination, substitution, regulation or support of physiological structure or physiological process; the support or maintenance of life; pregnancy control Provide information for medical or diagnostic purposes by examining samples from the human body.
The state implements classified management of medical devices according to the degree of risk.
The first is the low degree of risk, and the implementation of routine management can ensure its safe and effective medical devices.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices that require special measures to strictly control and manage to ensure their safety and effectiveness
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