Medical device safety knowledge

Categories:Company News
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Time of issue:2021-05-27 17:02
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(Summary description)Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software.

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Medical device safety knowledge

Categories:Company News
Author:
Origin:
Time of issue:2021-05-27 17:02
Views:

Information

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software.

1. 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, and they must have a clear mechanism of action and indications. And some unscrupulous businesses tend to exaggerate the therapeutic and health effects of daily necessities and mislead consumers with their medical devices. Therefore, relevant state departments stipulate that all daily necessities and decorations belonging to people, such as clothes, hats, shoes, socks, bracelets, earrings and other products, no matter what materials they use, shall not be registered as medical devices, and enterprises shall not Promote the therapeutic and diagnostic functions of the product.

2. From a clinical point of view, syringe manufacturers can divide the medical equipment into several categories?

(1) Large-scale equipment, 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 ventilators, anesthesia machines, and monitors.

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