CT machines belong to Class III medical devices.
Class III medical devices are:
Medical devices used for implantation in the human body or to support the maintenance of life, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, patient invasive monitoring system, IOLs, invasive endoscopy, ultrasound scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpel, microwave therapy instrument.
Medical nuclear magnetic **** vibration imaging equipment, X-ray therapy equipment, more than 200mA X-ray machine, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, disposable sterile syringes, disposable infusion sets, transfusion apparatus, CT equipment.
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Extended information: List of materials required to apply for a Class III medical device: (a) a copy of business license, organization code certificate; (b) a copy of the registration certificate and product technical requirements of the medical device produced held by the applicant company;? (C) legal representative, a copy of the identity of the person in charge of the enterprise; (D) production, quality and technical personnel in charge of the identity, education, title certificates; (E) production and management, quality inspection positions of practitioners, education, title lists; (F) the production site of the supporting documents, there are special requirements for the production environment also Should be submitted to the facilities, environment, copies of documents; (vii) the main production equipment and inspection equipment directory; (viii) quality manuals and procedural documents; (ix) the process flow diagram; (j) proof of authorization of the person in charge; (xi) other supporting information. /baike.baidu.com/item/%E4%B8%89%E7%B1%BB%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0/8587703?fr=aladdin#1 "target="_blank "title="Baidu Encyclopedia - Class III Medical Devices">Baidu Encyclopedia - Class III Medical Devices