I. Positive answer
1, two copies of the application form and one electronic filing document;
2, the original and one copy of the "pre-approval of the enterprise name notice" or "industrial and commercial business license" copy issued by the administrative department for industry and commerce;
3, application report. Including the introduction of enterprise personnel, scale of operation, business scope and other content;
4, business premises, warehouse premises and property certificates or lease agreement and a copy of the lessor's property certificates;
5, business premises, warehouse layout plan;
6, the proposed approach to determine the person in charge of the person responsible for the enterprise, the person in charge of the quality of the person in charge of the identity card, proof of academic qualifications And personal resume;
7, business quality management standardized document catalog, including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents;
8, the enterprise has been installed in the product purchasing, sales and inventory information management system, print a copy of the information management system home page.
Three types of medical devices after market research is basically in ten thousand to eighteen thousand or so.
Two, analyze the details
Production of class III medical devices, should be through clinical verification. By the State Council drug supervision and management department for examination and approval, and issued a certificate of registration for the production of products. The state of the safety and effectiveness of class III medical devices to take strict control management.
Third, what are the third class of medical devices
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 magnetic **** vibration imaging equipment. x-ray therapeutic equipment, X-ray machines more than 200mA, 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, blood transfusion, CT equipment and so on.
Four, what is the third class of medical devices
The third class of medical devices is the highest level of national medical devices, refers to implanted in the human body, used to support, maintain life, the human body has a potential danger to its safety, effectiveness must be strictly controlled medical devices.