Class III medical devices are:
Medical devices that are used for implantation in the human body or to support the maintenance of life, which are potentially dangerous to the human body, and whose 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.
Expanded Information:
Application for Class III medical device list of materials required:
(a) business license, organization code certificate Copy;
(ii) the applicant company holds the registration certificate of the medical device produced and a copy of the technical requirements of the product;
(iii) a copy of the legal representative, the person in charge of the enterprise identification;
(iv) production, quality and technical personnel in charge of the identity of the person, academic qualifications, professional title certificates;
(e) the production and management, quality inspection positions Practitioners list of academic qualifications, titles;
(F) the production site documents, there are special production environment requirements should also be submitted to the facilities, environment, a copy of the documents;
(VII) the main production equipment and inspection equipment catalog;
(VIII) quality manuals and procedural documents;
(IX) the process flow diagram;
(X) the authorization of the operator. (J) proof of authorization of the operator;
(k) other supporting information.