Enterprise registered address should be clear property rights. Its business premises should be equipped with well-functioning fixed telephone, fax machine, computer, network access devices, filing cabinets and other office equipment, a clean environment, the actual use of the area of not less than 80 square meters.
Category A: the business scope includes Class A medical devices, the actual use of its warehouse area of not less than 200 square meters
Category B: the actual use of the warehouse area of not less than 40 square meters. Shall not be entrusted distribution.
Category C: the actual use of its warehouse area of not less than 40 square meters.
Category D: the actual use of its warehouse area of not less than 40 square meters.
Category E: the actual use of its warehouse area of not less than 40 square meters.
Category F: the business scope of medical devices containing class F, the actual use of its warehouse area of not less than 40 square meters.
In vitro diagnostic reagents: corporate office, the actual use of business premises area of not less than 100 square meters. The actual use of the warehouse area of not less than 60 square meters. Cold storage volume of not less than 20 cubic meters.
At the same time operating A, B class, the warehouse shall be 200 square meters, the personnel shall be B class requirements.
At the same time operating C, D and not entrusted to the distribution, the warehouse must be 40 square meters.
At the same time all categories of business, the warehouse shall be 200 square meters, personnel, equipment and systems shall be B + E requirements.
And so on.
In vitro diagnostic reagent category warehouse shall not be with the ordinary two or three categories of warehouse **** there.