The following is my answer, I hope it can help you.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including required computer software; the utility of which is obtained primarily by physical and other means, not by pharmacological, immunological, or metabolic means, or which, although involved in these means, only plays an auxiliary role; The purposes are:
1. Diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. Diagnosis, monitoring, treatment, alleviation or functional compensation of injury;
3. Examination, substitution, modulation or support of physiological structures or processes;
4. Support or maintenance of life;
5. Pregnancy control;
6.
6. providing information for medical or diagnostic purposes through the examination of samples from the human body.
In China, products that fall under the definition of medical devices are required to be regulated by the market supervision and administration authorities in accordance with the Regulations on the Supervision and Administration of Medical Devices. According to the risk level of not using medical devices, China will be divided into three categories for management:
The first category is a low risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.
The second category is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices.
The third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
In our daily lives, we use the vast majority of Class I medical devices and a small number of Class II medical devices, as well as a very small number of Class III medical devices.
Second, the daily use of medical devices
Speaking of medical devices, may first think of CT machines, electrocardiographs and so on, these in our contact with the film and television drama often appear in the "big star". But you may not realize that some of the "dragons" that often accompany the camera, they are also medical devices!
Can be roughly summarized into the following categories
1. In the drugstore is easy to buy:
such as bandages, bandages, cotton swabs, cotton swabs, cotton balls, etc., belonging to the first class of medical devices.
There are also some thermometers, sphygmomanometers, home blood glucose meters, blood glucose test strips, pregnancy diagnostic test strips (early and early pregnancy test strips), ovulation detection test strips, etc., belonging to the second category of medical devices.
2. Ophthalmology-related products:
First of all, it is the soft corneal contact lenses (commonly known as contact lenses), in the medical device belongs to the ophthalmic apparatus class ophthalmic orthopedic and protective apparatus class I product category, and its related nursing care products (nursing care), all belong to the third class of medical devices, is considered to be daily life in contact with the level of the highest level of medical equipment.
There are also some medical devices that we don't pay much attention to, such as our common vision charts, children's graphic vision cards, for vision testing or amblyopia, blindness screening. They belong to the first class of medical devices. More special is the liquid crystal vision table, in the medical device classification catalog, mainly used for vision determination, is the second class of medical devices.
3. Some rehabilitation devices often seen in daily life:
Crutches: belong to the first class of medical devices. Including axillary crutches, medical crutches, elbow crutches, walking aids, walking frames, standing frames, paraplegic walking supports, standing