CT machines belong to three types of medical devices.

The third category of medical devices includes:

Medical devices which are used for implanting into human body or supporting life, are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripsy, invasive patient monitoring system, intraocular lens, invasive endoscope, ultrasonic scalpel, color ultrasonic imaging equipment, laser surgical equipment, high-frequency electrotome and microwave therapeutic apparatus.

medical magnetic resonance imaging equipment, X-ray therapy equipment, X-ray machines over 2mA, medical high-energy equipment, artificial heart-lung machines, internal fixation equipment, artificial heart valves, artificial kidneys, respiratory anesthesia equipment, disposable sterile syringes, disposable infusion sets, blood transfusions, CT equipment, etc.

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Extended information:

List of materials required for applying for Class III medical devices:

(1) Copies of business license and organization code certificate;

(2) A copy of the registration certificate and technical requirements of the medical devices produced by the applicant enterprise; ?

(3) photocopies of the identity certificates of the legal representative and the person in charge of the enterprise;

(4) a copy of the identity, education background and professional title certificate of the person in charge of production, quality and technology;

(5) List of educational background and professional titles of employees in production management and quality inspection posts;

(6) certification documents of the production site. If there are special requirements for the production environment, copies of certification documents of facilities and environment shall also be submitted;

(7) Catalogue of main production equipment and inspection equipment;

(8) quality manual and procedure documents;

(9) process flow chart;

(1) certificate of authorization of the agent;

(11) other supporting documents.

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