1. The use area of the business premises shall not be less than 40 square meters, and the use area of the business premises of the legal person branch shall not be less than 25 square meters (except for those set up across regions and cities); Operating hearing AIDS, the use area of business premises shall not be less than 25 square meters; Sales of contact lenses and care solutions, business premises use area shall not be less than 10 square meters.
2, warehouse area should be not less than 30 square meters; For the operation of disposable sterile medical devices, the warehouse shall be in the same building, and the use area shall not be less than 200 square meters.
The state has strict classification of medical devices, and the third category of medical devices is the highest level of medical devices, which must also be strictly controlled. They refer to medical devices implanted in human body to support and maintain life, which are potentially dangerous to human body, and their safety and effectiveness must be strictly controlled.
Extended data
Business scope of three types of registered medical device companies:
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.
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.
Baidu encyclopedia-three kinds of medical devices