A medical apparatus is an instrument, device, appliance, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including computer software required. Its utility is obtained primarily by physical means, rather than by pharmacological, immunological or metabolic means, or although these means are involved but only play an auxiliary role. The purpose of a medical apparatus is the diagnosis, prevention, monitoring, treatment or mitigation of diseases, the diagnosis, monitoring, treatment, mitigation or functional compensation of injuries, the examination, replacement, regulation or support of physiological structures or processes, life support or maintenance, pregnancy control, and the provision of information for medical or diagnostic purposes by examining samples from the human body.
According to the "Regulations on the Supervision and Administration of Medical Apparatus", medical apparatus is divided into three categories according to the degree of risk from low to high:
Class I medical apparatus: the degree of risk is low, and the implementation of routine management can ensure safety and effectiveness. Common products include basic surgical instruments (such as scalpels, scissors, forceps), medical dressings (such as gauze bandages, band-aids, medical cotton swabs), protective equipment (such as medical examination gloves, surgical gowns, surgical caps) and auxiliary devices (such as hospital beds, wheelchairs, urine collection bags), etc.
Class II medical apparatus: the degree of risk is moderate, and strict control and management are required. Common products include diagnostic equipment (such as thermometers, sphygmomanometers, electrocardiograms, electroencephalograms), rehabilitation equipment (such as hearing aids, magnetic therapy equipment, rehabilitation training equipment), testing equipment (such as biochemical analysis systems, blood glucose meters and test strips) and medical materials (such as medical absorbent cotton, non-absorbable sutures, condoms), etc.
Class III medical apparatus: high risk, special measures need to be taken to strictly control management. Common products include implantable devices (such as pacemakers, artificial joints, vascular stents), life support equipment (such as respirators, anesthesia machines, hemodialysis devices), imaging equipment (such as CT, MRI equipment, ultrasound tumor focusing knife) and high-risk consumables (such as disposable sterile syringes, infusion sets, blood transfusion sets).
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Guangzhou City, Guangdong Province