Registered Class III medical device company's scope of business:
Sales of medical devices 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 apparatus; Class II: clinical test 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.
Extended information:
p>Application for Class III medical device list of materials required:
(a) business license, organization code certificate copy;
(b) the applicant company holds a copy of the registration certificate of the medical device produced and 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 and management, quality inspection positions of practitioners, education, title lists;
(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) the process flow diagram;
(j) proof of authorization of the person in charge;
(xi) other supporting information.
Baidu Encyclopedia - Class III Medical Devices