Medical device business enterprises should meet the following conditions:
(a) with its operation of medical devices appropriate business premises and environment;
(b) with its operation of medical devices appropriate quality inspection personnel;
(c) with its operation of medical device products appropriate technical training, maintenance and other after-sales service capabilities
(c) have the technical training, maintenance and other after-sales service capabilities appropriate to their medical device products.
1. "Registered address" and "warehouse address" can not be set up in residential areas, and must be consistent with the certificate of property rights or the right to use the house and other relevant documents, "office actual use area "and" the actual use of the warehouse area "must be consistent with the certificate of property rights or the right to use the area of the house;" registered address "and" warehouse address "should be filled in clearly specific door number," "warehouse address". Fill in the specific door, floor and room number should be clear;
2. Office actual use of the area "not less than 80m, the actual use of the warehouse area": not less than 200 m of the business class A, not less than 100 m2 of class D, and other classes of not less than 40 m2;
3. Layout of the business premises Floor plan must be marked business departments, the labeling must be clear, marked size and area; Warehouse layout plan must be clearly divided into qualified area, unqualified area, to be inspected area, return area, the labeling must be clear, marked size and area;
And so on, quite a lot!