CT machines belong to the third class of medical devices.
Class III medical devices are:
Used for implantation in the human body or to support the life-sustaining, potentially dangerous to the human body, its safety and effectiveness must be strictly controlled medical devices. 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 device.
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, one-time-use sterile syringes, one-time-use infusion sets, transfusion apparatus, CT equipment.
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Extended information: List of materials required for the application of Class III medical devices: (a) Business license, organization code certificate Copies; (ii) the applicant company holds a copy of the registration certificate of the medical device produced and product technical requirements;? (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 management, quality inspection positions of practitioners, education, title list; (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) process flow diagrams; (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