Definition of medical device

Medical devices refer to instruments, equipment, appliances, materials, or other items used on the human body alone or in combination, including the required software; their effects on the surface and in the body of the human body are not obtained by pharmacological, immunological or metabolic means , But these methods may participate and play a certain auxiliary role; their use aims to achieve the following expected purposes:

(1) Prevention, diagnosis, treatment, monitoring and alleviation of diseases;

(2) Diagnosis, treatment, monitoring, mitigation, and compensation for injury or disability;

(3) Research, substitution, and adjustment of anatomical or physiological processes;

(4) Pregnancy control.