What are the classifications of medical devices? How are they classified? I believe everyone feels that when I go to hospitals or other inspection institutions, there are not only the simple equipment inspections in the past, but also many advanced instruments, and the types of instruments are very diverse. This also shows that with the improvement of the level of science and technology, the types of medical devices have increased, and the medical level has also improved. In order to better protect people's medical safety, the State Food and Drug Administration has made some classifications of medical devices, but there are different classifications according to different uses. Let's take a look at the common classifications now:
First, the classification of supervision and management
The supervision and management classification needs to be understood in accordance with the "Medical Device Classification Catalog"
1. Equipment: 6801, 6802, 6803, 6804, 6805, 6806, 6807, 6808, 6809, 6810, 6812, 6813, 6816, 6820, 6827;
2. Equipment category: 6821 (Class II), 6822 (Class II) 6823, 6824, 6825, 6826, 6831, 6834, 6840, 6841, 6845, 6854, 6855, 6856, 6857, 6858;
3. Large-scale medical equipment: 6824, 6825, 6828, 6830, 6832, 6833;
4. Implantation, intervention and artificial organs: 6821 (Class Ⅲ), 6822 (Class Ⅲ) 6846 (except hearing aids), 6877;
5. Medical materials: 6863, 6864, 6865, 6866 (except 6866-1);
6. Disposable sterile type: 6815, 6866;
7. Software: 6870;
8. Fitting categories: contact lenses, hearing aids; among them, in-vitro diagnostic reagents and medical device products that are otherwise specified by the State Drug Administration shall follow its regulations.
Second, medical functional classification
1. Diagnostic: physical diagnostic equipment (thermometer, blood pressure meter, microscope, audiometer, various physiological recorders, etc.), imaging (X-ray machine, CT scan, magnetic resonance, B-ultrasound, etc.), analytical instruments (each Various types of counters, biochemical, immunological analysis instruments, etc.), electrophysiological (such as electrocardiograph, electroencephalogram, electromyography, etc.), etc.;
2. Therapeutic: ordinary surgical equipment, light-guided surgical equipment (fiber endoscope, laser treatment machine, etc.), auxiliary surgical equipment (such as various anesthesia machines, ventilators, extracorporeal circulation, etc.), radiotherapy machinery (such as deep X-ray Treatment machine, cobalt 60 treatment machine, accelerator, gamma knife, various isotope treatment devices, etc.), other categories: microwave, hyperbaric oxygen.
Third, equipment classification
The first category: medical devices that can ensure their safety and effectiveness through routine management;
The second category: medical devices whose safety and effectiveness should be controlled;
The third category: implanted into the human body; used to support and maintain life; medical devices that are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.
