Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; their utility is obtained mainly through physical means, not through pharmacological, immunological or metabolic means, or although these means are involved but only play a supplementary role; their purpose is the diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation or functional compensation of injury; test, replacement, regulation or support of physiological structures or processes; life support or maintenance. diagnosis, prevention, monitoring, treatment, or mitigation of disease; diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; examination, substitution, regulation, or support of physiological structures or processes; support or maintenance of life; pregnancy control; and provision of information for medical or diagnostic purposes through the examination of samples from the human body.
Medical devices are divided into three categories:
The first category, medical devices whose safety and effectiveness are adequately ensured by routine management.
The second category, the safety and effectiveness of medical devices should be controlled.
The third category, for implantation in the human body, in support of life support; potential danger to the human body, its safety and effectiveness must be strictly controlled medical devices.
Medical device classification to implement the "Classification of Medical Devices Catalog" and "Rules for the Classification of Medical Devices".