Industry News

These inconspicuous things are actually medical devices

2021-11-22
When it comes to medical devices, many small partners will take it for granted that they are "noble and glamorous" and "obscure" and will only appear in hospitals. In fact, medical devices are very common in our lives, don't you believe it? Then let's get to know them together.
1. Take you to know medical equipment
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other related items used directly or indirectly on the human body, including the required computer software; their utility is mainly obtained through physical methods, not through pharmacology. It can be obtained through scientific, immunological, or metabolic methods, or although these methods are involved but only play an auxiliary role; its purpose is:
① Diagnosis, prevention, monitoring, treatment or alleviation of diseases.
②Injury diagnosis, monitoring, treatment, alleviation or functional compensation.
③Examination, substitution, adjustment or support of physiological structure or physiological process.
④ Support or maintenance of life.
⑤Pregnancy control.
⑥Provide information for medical or diagnostic purposes by examining samples from the human body.
In my country, products that fall under the definition of medical devices must be supervised by the market supervision and management department in accordance with the "Regulations on the Supervision and Administration of Medical Devices." According to the degree of risk of not using medical devices, my country divides them into three categories for management:
The first category is low-risk medical devices, and the implementation of routine management can ensure their safety and effectiveness.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.
The third category is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness.
2. What are the common medical devices in life?
In our daily life, the vast majority of the medical devices we use are the first-class medical devices, a small amount of the second-class medical devices, and a very few third-class medical devices.
① Equipment available in pharmacies
Such as bandages, bandages, cotton swabs, cotton swabs, cotton balls, etc., these belong to the first category of medical devices.
There are also thermometers, sphygmomanometers, home blood glucose meters, blood glucose test strips, pregnancy diagnostic test strips (early pregnancy test strips), ovulation test strips, etc. They belong to the second category of medical devices.
②Equipment related to ophthalmology
Contact lenses and their care solutions belong to the third category of medical devices, and they are also the highest-level medical devices encountered in daily life.
In addition, products related to ophthalmology include visual acuity charts, graphic visual acuity cards for children, etc., which belong to the first category of medical equipment.
It should be noted that the liquid crystal eye chart belongs to the second category of medical devices in the medical device classification catalog.
③Rehabilitation equipment
·Crutch: It belongs to the first category of medical equipment. Including axillary crutches, medical crutches, elbow crutches, walking aids, walking frames, standing frames, paraplegic walking braces, standing balance training braces, etc.
·Hearing aids: belong to the second category of medical devices. An electronic device usually used to amplify sound and compensate for hearing loss.
· Wheelchair: It belongs to the second category of medical equipment. It is used to compensate patients with mobility impairments for transportation and walking functions.
④Beauty tools
For example, tools used for ear piercing belong to passive surgical instruments in the medical device classification catalog, surgical instruments-puncture guides. Belongs to the first category of medical devices.
⑤Oral denture equipment
According to the different production materials, the level in the medical device classification catalog is different.
Metal materials and products for dentures belong to the second category of medical devices.
Ceramic materials and products for dentures belong to the second category of medical devices.
According to the different main components of the polymer materials and products for dentures, some belong to the second category of medical devices, and some belong to the third category of medical devices.
⑥Other equipment

Condoms, the most common are the second-class medical devices, and a few are the third-class medical devices. 





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