CT machines belong to the third class of medical devices.
Class III medical devices are:
Medical devices used for implantation in the human body or to support life-sustaining, potentially dangerous to the human body, the safety and effectiveness of which 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: Application for Class III medical device list of materials required: (a) business license, organization code certificate copy; (b) the applicant enterprise held by the production of Medical device registration certificate and a copy of 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 list of academic qualifications, titles; (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