How to classify medical device products
The first category is low-risk medical devices whose safety and effectiveness can be guaranteed by implementing routine management.
Such as surgical instruments (knives, scissors, forceps, tweezers, needles, hooks), stethoscopes (no power), mirrors, reflectors, medical magnifiers, (Chinese medicine) scraping plates, adhesive plasters, breathable tape, surgical gowns , Surgical caps, examination gloves, liquid collection bags, etc. belong to a class of products.
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The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.
Such as sphygmomanometers, clinical thermometers, electrocardiographs, electroencephalography machines, operating microscopes, (Chinese medicine) acupuncture needles, hearing aids, skin staples, condoms, contraceptive caps, sterile medical gloves, sleep monitoring system software, ultrasound three-dimensional system software , Pulse meter software, etc. belong to the second category of products.
The third category is medical devices that have higher risks and require special measures to strictly control and manage to ensure their safety and effectiveness.
Such as cardiac pacemakers, external counterpulsation devices, vascular endoscopes, ultrasound tumor focusing knives, high-frequency electrosurgical units, microwave scalpels, medical magnetic resonance imaging equipment, Co60 treatment machines, positron emission tomography devices (PECT), Implant equipment, implantable artificial organs, vascular stents, intravascular catheters, disposable infusion sets, blood transfusion sets, etc. belong to three categories of products.
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