Traditional Culture Encyclopedia - Photography and portraiture - What is the third business scope of medical devices?
What is the third business scope of medical devices?
Sales of the third category of medical instruments: medical electronic instruments and equipment, medical optical instruments, instruments and endoscope equipment, medical magnetic vibration equipment, medical X-ray equipment, operating room, emergency room and outpatient equipment and appliances; The second category: clinical laboratory analytical instruments. Sales of computer software and auxiliary equipment, electronic products, stationery, handicrafts (excluding cultural relics), building materials, mechanical equipment, furniture, instruments and meters; Economic and trade consultation.
Retail injection puncture instruments, medical polymer materials and products, clinical inspection and analysis instruments, in-vitro diagnostic reagents, medical electronic instruments and equipment, disinfection and sterilization equipment and appliances.
Extended data:
List of materials required to apply for Class III medical devices:
(a) a copy of the business license and organization code certificate;
(2) A copy of the registration certificate and product technical requirements of the medical devices produced by the applicant enterprise; ?
(3) Copies of the identity certificates of the legal representative and the person in charge of the enterprise;
(four) the identity, education and title certificate of the person in charge of production, quality and technology;
(5) List of academic qualifications and titles of employees in production management and quality inspection positions;
(six) the production site certification documents, if there are special requirements for the production environment, it shall also submit a copy of the facilities and environmental certification documents;
(seven) the main production equipment and inspection equipment directory;
(eight) quality manuals and program documents;
(9) Process flow chart;
(10) authorization certificate of the agent;
(eleven) other supporting materials.
Baidu encyclopedia-three kinds of medical equipment
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