The state of medical devices in accordance with the risk level of implementation of classification management.
The first category is the medical devices with low risk, which can be guaranteed to be safe and effective by routine management.
The second category is a medium risk, need to strictly control the management to ensure the 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 its safety and effectiveness of medical devices.
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 the required computer software.
Utility is obtained primarily by physical and other means, not by pharmacological, immunological or metabolic means, or is involved but only in an ancillary manner.
Purposes are the diagnosis, prevention, monitoring, treatment, or alleviation of disease; the diagnosis, monitoring, treatment, alleviation, or functional compensation of injury; the examination, replacement, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.
Expanded Information:
One, commonly used medical equipment
1, home health care equipment:
Pain massage equipment, home health care self-testing equipment, Sphygmomanometer, electronic thermometer, multifunctional therapeutic instrument, laser therapeutic instrument, blood glucose meter, diabetes therapeutic instrument, vision improvement equipment, sleep improvement equipment, oral hygiene and health supplies, home emergency treatment products.
2, home health care massage products:
Electric massage chairs/beds, massage rods, massage whackers, massage pillows, massage cushions, massage belts, qi and blood circulation machine, foot baths, foot massagers;, hand-held massager, massage bathtubs, dumping belt, therapeutic instrument, foot physiotherapy, weight loss belts, car cushions, kneading cushions, massage chairs, breast augmentation, beauty massagers and so on.
3, home medical rehabilitation equipment:
Home cervical and lumbar traction device, traction chair, physical therapy equipment, sleep instrument, massage instrument, functional chairs, functional beds, supporters, medical inflatable air cushion; oxygen machine, decocting machine, hearing aids and so on.
4, home care equipment:
Family rehabilitation nursing aids, female pregnancy and baby care products, home use of gas supply and delivery equipment; oxygen cylinders, oxygen bags, family first aid kits, blood pressure monitors, glucose meters, nursing beds and so on.
5, commonly used medical equipment in hospitals:
Trauma disposal vehicle, surgical beds, surgical lights, monitors, anesthesia machines, respiratory machines, blood cell analyzers, differentiation analyzers, enzyme markers, plate washer, urine analyzer, ultrasound (ultrasound, ultrasound, etc.), X-ray machines, magnetic *** vibration and so on.
Special rectification
March 17, 2014, the State Food and Drug Administration held a news conference, from now on, the State Food and Drug Administration will focus on the country for a period of five months of medical equipment "five rectification" special action.
Focusing on medical device false registration declaration, illegal production, illegal operation, expanding publicity, the use of unlicensed products five kinds of behavior.
Special action to focus on key products, key enterprises, key case clues as a breakthrough, through unannounced visits to the investigation, centralized investigation, raids and inspections of a combination of ways to crack down on illegal behavior, and further standardize the market order.
The State Food and Drug Administration requires that the special action, found in violation of the law, all from the fast, strict, serious treatment, and in accordance with the laws and regulations of the upper limit to be punished; the circumstances are serious, all the revocation of the license of the manufacturer and operator and the product.
Suspected of committing a crime, all transferred to the public security organs for the investigation of criminal responsibility according to law; the existence of hidden safety hazards of the product, all stop the sale and use, and order companies to recall and supervise the destruction.
Reference:
Baidu Encyclopedia-Medical Devices