Legal analysis: 1, according to the performance and requirements of medical devices, the product warehouse temperature control at 1 a 30 degrees, humidity between 45 a 75%.
2, the warehouse should be configured with padded warehouse board and other facilities to maintain the distance from the ground, configure the measurement and regulation of temperature and humidity facilities, configuration of light and ventilation facilities, configuration of lighting facilities to meet the requirements of the configuration of the fire, safety rodent, insect and dust control facilities.
3, no sources of pollution around the warehouse, a clean environment. Treasury and business premises should be isolated facilities, the area and the scale of operation is appropriate.
4, the storage and display of product quality problems, should be promptly reported to the quality control personnel to confirm and deal with the quality of the personnel responsible for filling out the "medical device products stop selling notice". Problematic products will be placed in the unqualified area for storage, to be identified after the cause of the return or destruction of the treatment, the results must be recorded. If the product is fake or inferior, it should be reported to the local Food and Drug Administration to supervise the processing.
5, the warehouse should be regularly cleaned and disinfected, and do a good job of anti-theft, fire, moisture, mildew, insects, rodents, anti-pollution work.
6, the various types of conservation instruments and equipment and facilities should be regularly inspected.
Legal basis: "supervision and management of medical devices regulations"
Article 47 of the transportation and storage of medical devices shall comply with the requirements of the medical device instructions and labeling; temperature, humidity and other environmental conditions have special requirements, corresponding measures should be taken to ensure that the safety and effectiveness of medical devices.
Article 48 The use of medical devices should be used with the medical device species, the number of storage space and conditions appropriate to the use of medical devices. Medical device use unit shall strengthen the technical training of staff, in accordance with product instructions, technical specifications and other requirements for the use of medical devices.
Medical equipment using units configured with large medical equipment, should be in line with the State Council competent department of health to develop large-scale medical equipment configuration planning, and its functional positioning, clinical service needs are appropriate, with the appropriate technical conditions, supporting facilities and have the appropriate qualifications, capabilities, professional and technical personnel, and by the people's government at or above the provincial level of the competent department of health approval, to obtain a large medical equipment configuration License.
Large medical equipment configuration management by the State Council health department in conjunction with the relevant departments of the State Council. Catalog of large medical equipment by the State Council health department of the State Council departments concerned proposed, reported to the State Council for approval and implementation.