Enterprises should have with the scale and scope of operation of the business, independent of the living area of the business premises, the business premises should be spacious, bright, clean, with a fixed telephone and other office equipment, the operation of the medical equipment stores, the use of the area should be not less than 20 square meters.
Businesses that deal with fitting products, the use of business premises area (including the same site warehouse) should be not less than 50 square meters.
Enterprises operating corneal contact lenses, the business premises should be set up: examination room, optometry room, fitting table and hand-washing sinks, and has good hygiene conditions. Should be equipped with visual acuity meter, inspection glasses, lens box, computerized optometry or comprehensive optometry, slit lamps, etc. (rigid corneal contact lenses should increase the keratometer) instruments and equipment.
Hearing aid business enterprises, its business premises should be set up: reception room, medical examination room, hearing test room, etc., and have a good environment and health conditions. Should be equipped with professional hearing test equipment or instruments, at least should include: audiometer with air bone conduction test function, tuning fork, otological examination instruments and special equipment for hearing aid commissioning.
With the scale and scope of business with the appropriate warehouse, the minimum area for the operation of different categories of products warehouse regulations are as follows (except for the operation of medical equipment stores):
Instruments: 20 square meters. Equipment, apparatus category: 30 square meters. Implantation, intervention and artificial organs and diagnostic reagents: 10 square meters. Medical materials: 50 square meters. Disposable sterile class: 60 square meters. A single large medical equipment, software products can
No warehouse.
The warehouse should be divided into areas to be inspected, qualified products area, shipping area, non-conforming products area, return area and other special areas, the above areas should be clearly marked, the bulk of the goods can be hung to show the color of the sign. (Qualified, shipped using green mark; pending inspection, return using yellow mark; unqualified using red mark).
The walls, ceiling and floor of the warehouse should be clean, smooth, tightly structured doors and windows.
The environment around the warehouse should be clean, dry terrain, no dust, no harmful gases, no pollution sources.
The warehouse should have safe electricity, lighting, light, ventilation, dust, fire, moisture, mold, pollution, insects, rodents and other equipment, as well as storage facilities and equipment in line with the requirements of the characteristics of medical equipment products. Operation of temperature and humidity requirements of the product, the warehouse should be detected and adjusted temperature and humidity equipment, and have to ensure that the product in the transportation process safe and effective facilities and equipment.