Legal analysis: 1. the operation of the second class, the third class of medical equipment products, medical equipment warehouse area should be not less than 40 square meters, the use of legal entity branches of the warehouse area should be not less than 25 square meters (except across the regional municipalities set up); the operation of hearing aids, the use of warehouses should be not less than 25 square meters; the operation of contact lenses and nursing fluids, the warehouse area should be not less than 10 square meters. Business Class II, Class III medical devices (hearing aids, contact lenses and nursing fluids, single-use sterile medical device products in vitro diagnostic reagents, 6846 implantable materials and artificial organs, 6877 interventional devices, except), the use of medical equipment warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be In the same building, medical equipment warehouse area should not be less than 200 square meters. 3 legal entity branches (except for the establishment of the city across the region) and specializing in medical equipment equipment can not set up a separate warehouse, but it should be stamped with the legal entity or authorized to operate the product manufacturer (including the import agent) the original seal of the original seal of the relevant procurement and distribution of uniform quality management, installation and after-sales service and other commitments. After-sales service and other commitments, as well as the franchise product registration, authorization documents and other evidence.4. Business hearing aids or contact lenses and their care liquid, can not set up a warehouse, but there should be a special cabinet.
Legal basis: "Medical Device Business License Management Measures" Article 3 of the operation of second and third class medical devices should hold a "Medical Device Business License", but in the circulation process through the routine management to ensure its safety, effectiveness of a few second class medical devices can not apply for a "Medical Device Business License". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.