What is a medical device?
Refers 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; Its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;
(4) Life support or maintenance;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from human bodies.
In China, 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 using medical devices, my country divides them into three categories for management:
The first category is a medical device with a low degree of risk, and routine management can ensure its safety and effectiveness.
The second category is medical devices with moderate risks that 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.
Daily use medical equipment
1.Easy to buy in pharmacies:
Such as bandages, bandages, cotton swabs, cotton swabs, cotton balls, etc., belong to the first category of medical equipment.
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., which belong to the second category of medical devices.
2. Ophthalmology related products:
The first is the soft contact lens (commonly known as contact lens), which belongs to the first class of ophthalmic equipment, ophthalmic correction and protective equipment, and its related care products (care solution) belong to the third category of medical equipment The highest-level medical equipment that you come into contact with in daily life.
There are also some medical devices that are not of much concern to everyone, such as our common eye chart and children’s graphic visual acuity card, which are used for vision testing or amblyopia and blindness screening. It belongs to the first category of medical devices.
3.Some beauty tools:
For example, tools used for ear piercing belong to passive surgical instruments in the medical device classification catalog, surgical instruments-puncture guides. It belongs to the first category of medical devices.
4.Finally, there is this…
Condom. Yes, it is also a medical device, and it is not the first category, the second category is common, and a few are the third category. It is a barrier contraceptive device under pregnancy control device.
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