What is a "medical device"

There are three types of medical devices, of which Class I is implanted in human body (except condoms, hehe), Class II needs strict management, and Class III has nothing to do with human body and can be sold in retail stores without strict management (such as thermometers). As for the official strict explanation, you can find it in the National Regulations on the Supervision and Administration of Medical Devices.

Generally speaking, that kind of skimmer should belong to the word Jian Xie, that is, health care products and equipment. If you want to confirm what a product belongs to, you must look at its approval number "Mechanical Zhunzi" for medical devices and "Food Hygiene Zhunzi" for health products.

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Copy the following paragraph for you:

Medical devices refer to instruments, equipment, appliances, materials or other articles used for human body alone or in combination, including required software; Its effects on human body surface and in vivo are not obtained by pharmacological, immunological or metabolic means, but these means may participate and play a certain auxiliary role; Its purpose is to achieve the following expected purposes:

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

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

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

(4) Pregnancy control.

For example, CT machines, disposable needles, gauze and condoms are all medical devices.