Medical device
Date:2025-03-03 Click:648
Medical devices used on the surface and inside of the human body are not obtained through pharmacological, immunological, or metabolic means, but may involve these means and play a certain auxiliary role; Its use aims to achieve the following expected purposes:
(1) Prevention, diagnosis, treatment, monitoring, and alleviation of diseases;
(2) Diagnosis, treatment, monitoring, relief, and compensation for injuries or disabilities;
(3) Research, substitution, and regulation of anatomical or physiological processes;
(4) Pregnancy control.
Medical devices are divided into three categoriesThe first category refers to medical devices that can ensure their safety and effectiveness through routine management.
The second category refers to medical devices whose safety and effectiveness should be controlled.
The third category refers to implantation into the human body; Used to support and sustain life; Medical devices that pose potential risks to the human body and require strict control over their safety and effectiveness.