Safety knowledge of medical devices

1. From a clinical point of view, what types of medical devices can be classified into equipment?
(1) Large equipment categories, such as: CT, MRI, PET/CT, DSA.
(2) Inspection and analysis equipment, such as: biochemical analyzer, blood cell counter, double-tube biological microscope, urine analyzer, microplate reader, plate washer, biological safety cabinet, ultra-clean workbench.
(3) Diagnostic equipment, such as: ultrasonic diagnostic equipment, various X-ray machines, and electrocardiographs.
(4) Critical emergency equipment, such as: ventilator, anesthesia machine, monitor

2. Can daily necessities be promoted and sold as medical equipment?
Medical devices are important medical products used by people to prevent, diagnose and treat diseases. They must have a clear mechanism of action and indications. And some unscrupulous businesses tend to exaggerate the therapeutic and health care effects of daily necessities, rely on their medical devices, and mislead consumers. Therefore, the relevant state departments stipulate that all daily necessities and decorations belonging to people, such as clothes, hats, shoes, socks, bracelets, earrings and other products, regardless of the materials used, shall not be registered as medical devices, and enterprises shall not Promote the therapeutic and diagnostic functions of the product.

Next:"Medical Device Classification Rules" (State Food and Drug Administration Order No. 15)