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What is a medical device?

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2022-11-24

 

Definition of medical devices: 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; whose utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or which are involved but only play an auxiliary role; whose purpose is : (a) Disease is diagnosed, prevented, and treated.
(a) Diagnosis, prevention, monitoring, treatment or mitigation of disease.
(ii) The diagnosis, monitoring, treatment, mitigation or functional compensation of an injury; (iii) The diagnosis, monitoring, treatment, mitigation or functional compensation of a physiological structure or physiological process
(iii) The examination, replacement, regulation, or support of physiological structures or processes
(iv) Life support or maintenance.
(v) Pregnancy control.
(vi) The examination of samples from the human body to provide information for medical or diagnostic purposes.

Keywords：Human Health

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