A list of materials required to apply for Class III medical devices:
(A) business license, organization code certificate copy; (B) the applicant company holds a copy of the registration certificate of the production of medical devices and product technical requirements; (C) legal representative, the person in charge of the enterprise a copy of the identity certificate; (D) production, quality and technical personnel in charge of the identity, education, professional title certificates Copy; (E) production management, quality inspection positions practitioners list of academic qualifications, titles; (F) the production site documents, there are special requirements for the production environment should also be submitted to the facilities, the environment, copies of documents; (G) the main production equipment and inspection equipment directory; (H) quality manuals and procedural documents; (IX) process flow diagram; (J) the operator's authorization; (K) other Proof of information.
Two, registered class III medical device company's scope of business:
Sales of medical equipment Class III: medical electronic instruments and equipment, medical optical instruments, instruments and endoscopic equipment, medical magnetic **** vibration equipment, medical X-ray equipment, operating room, emergency room, diagnostic and treatment room equipment and appliances; Class Ⅱ: clinical testing and analysis instruments. Sales of computer software and auxiliary equipment, electronic products, cultural goods, handicrafts (excluding cultural relics), construction materials, machinery and equipment, furniture, instruments and meters; economic and trade consulting.
Retail injection and puncture instruments, medical polymer materials and products, clinical testing and analysis instruments, in vitro diagnostic reagents, medical electronic instruments and equipment, disinfection and sterilization equipment and apparatus.
Three, the approval of three types of medical equipment license conditions:
1, the business premises should be used in an area of not less than 40 square meters, branches of legal entities should be used in an area of not less than 25 square meters of business premises (except across the regional municipalities set up); business hearing aids, the business premises should be used in an area of not less than 25 square meters; business contact lenses and nursing fluids, contact lenses and nursing fluid. Business premises should be no less than 10 square meters.
2, the warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
3, quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. Operating single-use sterile medical devices, there should be more than one medical device quality management system internal auditor certificate of internal auditor and other relevant application conditions.
Four, what are the third class of medical devices?
Used for implantation in the human body or to support life-sustaining, potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Such as implantable cardiac pacemakers, extracorporeal shock wave lithotripter, patient invasive monitoring systems, artificial crystals, invasive endoscopy, ultrasound scalpel, color ultrasound imaging equipment, laser surgical equipment, high-frequency scalpel, microwave therapy, medical nuclear magnetic **** vibration imaging equipment, X-ray therapeutic equipment, more than 200mA X-ray machine, medical high-energy equipment, artificial heart-lung machine, internal fixation devices, artificial heart valves, artificial kidney, respiratory anesthesia equipment, single-use sterile syringes, single-use infusion sets, blood transfusion, CT equipment and so on.