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. The purpose is the diagnosis, prevention, monitoring, treatment or alleviation of diseases; diagnosis, monitoring, treatment, alleviation or functional compensation of injuries; inspection, replacement, adjustment or support of physiological structures or physiological processes; life support or maintenance; pregnancy control; Provide information for medical or diagnostic purposes by examining samples from the human body.
In this battle of the COVID-19, medical devices have repeatedly made outstanding achievements. At the same time, with the rapid development of science and technology in my country and the obvious improvement of economic level, the medical level has been continuously improved, and various high-tech medical devices have gradually been recognized and accepted by the public. However, due to certain conditions, the production level of medical devices in my country is lower than that of individual developed countries. Therefore, many medical devices in my country are imported. Then, how much do you know about imported medical devices? What is the misunderstanding?
Misunderstanding of imported medical devices 1: Imported medical devices have a high degree of risk sharing and can only be seen and used in hospitals and other places, and must be used by medical personnel.
This is not right. in fact, in China, imported medical equipment is divided into three categories according to the professional level of operation and the degree of danger of medical equipment. In fact, many first and second types of medical equipment can be used in the home, such as blood pressure monitors, blood glucose meters, etc. Actually, masks also belong to the scope of imported medical equipment, as well as gauze, bandages and so on. In this category, there is no need for too many professional operations.
Misunderstanding of imported medical devices 2: Non-medical devices and medical devices will be indistinguishable.
In people’s life, many non-medical devices are used as medical devices, most of which exist in the fields of health care, fitness, etc., including health food, etc. This kind of comparison is easy to distinguish, mainly depends on the existence of medical device registration documents, some words It is a medical device, not a non-medical device.
Misunderstandings about the import of medical devices are 3: As long as imported medical devices are better than non-medical devices?
This issue is not comparable. The production and sales of imported medical devices do have to undergo strict inspections and many clinical trials before they can be sold. However, among the applicable population, the applicable population of imported medical devices is relatively small. On the contrary, the applicable population of other medical products is even greater. Diversity cannot be compared alone.
This is a common misunderstanding of imported medical devices. In many cases, imported medical devices are still relatively unfamiliar to everyone. These can be used as our usual accumulation of knowledge, and hope that no one has the opportunity to touch medical devices.
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