According to the on-site inspection records of Guangdong Medical Device Business License, the provisions are as follows:
The registered address of an enterprise should have clear property rights. Its business premises shall be equipped with fully functional fixed telephones, fax machines, computers, network access equipment, filing cabinets and other office equipment, with a clean environment and an actual use area of not less than 80 square meters. Class A: If the business scope includes Class A medical devices, the actual use area of the warehouse shall not be less than 200m2.
Class B: The actual use area of the warehouse is not less than 40 square meters. Shall not entrust distribution.
Class C: the actual use area of its warehouse is not less than 40 square meters.
Class D: The actual use area of its warehouse is not less than 40 square meters.
Category E: The actual use area of its warehouse is not less than 40 square meters.
Class F: If the business scope includes Class F medical devices, the actual use area of the warehouse shall not be less than 40 square meters.
In vitro diagnostic reagent: the actual use area of the office and business premises of the enterprise is not less than 100 square meter. The actual use area of the warehouse is not less than 60 square meters. The cold storage capacity is not less than 20 cubic meters.
When operating Class A and Class B at the same time, the warehouse area is 200 square meters, and the personnel meet the requirements of Class B. ..
At the same time, it operates C and D categories and does not entrust distribution. The warehouse needs 40 square meters.
If all categories are operated at the same time, the warehouse must be 200 square meters, and the personnel and equipment system must meet the requirements of B+E.
And so on.
In vitro diagnostic reagent warehouse shall not be * * * the same as ordinary secondary and tertiary warehouses.