Two, has obtained the "Medical Device Business Enterprise License" or "Medical Device Manufacturer's License" of the enterprise, set up in a different place of business (including branches, stores, departments, warehouses, etc.) to operate two or three types of medical devices, must be in accordance with the law in the local "Medical Device Business Enterprise License," or else, in accordance with the "Supervision and Management of Medical Devices Regulations" Article 38 Penalties.
Three, the medical device business enterprises to change the "medical device business license" approved business premises, should be "supervision and management of medical equipment business approach" (State Drug Administration Decree No. 19) Article XIV change procedures, did not apply for changes in accordance with the "supervision and management of medical equipment business approach" Article XIX for investigation and punishment.
Medical equipment business enterprises across provincial jurisdictions to set up additional warehouses regulatory requirements
A medical equipment business enterprises can set up additional warehouses across provincial jurisdictions, the warehouse should be set up in line with the requirements of the acceptance criteria for the medical equipment business enterprises where the warehouse is located, and has a warehouse with the main business interconnected with the Department of the computer management system capable of exchanging the storage of medical equipment, access to the warehouse data.
Second, across provincial jurisdictions to set up warehouses, should be operated by the enterprise to the "Medical Device Business License" of the licensing department to apply and submit the following relevant information stamped with the official seal of the enterprise (in duplicate):
(1) Medical Device Business License change application form;
(2) "Medical Device Business License" copy;
(3) a copy of the "industrial and commercial business license" copy;
(4) the proposed additional warehouse quality acceptance of personnel ID card, a copy of the certificate of academic qualifications or titles;
(5) the new warehouse property rights certificate or a copy of the lease agreement, geographic location map, floor plan and description of the storage conditions.
After the review of the licensing department, the provincial food and drug supervision and management department where the warehouse is located to assist in the inspection and acceptance in accordance with the conditions of the setup. After inspection and acceptance, the provincial food and drug supervision and management department where the warehouse should be the acceptance of the results in writing back to the licensing department (style see Annex 1, 2), the licensing department will be added to the warehouse address marked in the "medical device business license.
Third, after approval, the medical device business enterprises should be in accordance with the "supervision and management of medical devices regulations" and the relevant provisions of the license to set up warehouses for management and assume corresponding legal responsibility. Medical device business enterprises across provincial jurisdictions to set up warehouses can only engage in logistics activities related to the purchase and sale of the business.
Four, medical device business enterprises across the jurisdiction of the warehouse set up by the warehouse where the food and drug supervision and management department for day-to-day supervision.