The use of drugs and medical devices in accordance with the hospital class and non-hospital supervision and management. Hospital-type medical institutions, including various types of hospitals, maternal and child health centers and larger health centers. The specific standards for larger health centers by the provincial health administrative department, the provincial food and drug supervision and management departments. Article IV medical institutions, drugs and medical devices should follow the principle of safe, effective and reasonable. Article V above the county level people's government food and drug supervision and management department is responsible for the administrative region of the medical institutions of drugs and medical equipment use of supervision and management.
Health administrative departments in accordance with the division of labor responsible for the administrative area of medical institutions within the supervision and management of drugs and medical equipment use related matters.
Industry and commerce, price, quality and technical supervision, population and family planning and other relevant administrative departments, in accordance with their respective responsibilities to do a good job in medical institutions and medical equipment use of drugs and medical management. Article VI of the main medical institutions responsible for the use of drugs and medical equipment is fully responsible for the unit.
Medical institutions should be based on its size and management needs, set up drugs, medical equipment management organization or management personnel, establish a management system, clear and implement the responsibilities. Chapter II of the procurement and storage of drugs, medical devices Article 7 medical institutions shall establish drugs, medical equipment purchase inspection system, the relevant documents for inspection:
(a) from the drug, medical device manufacturers for the first time the procurement of drugs, medical devices, should check the "drug production license", drug approval documents or "medical device manufacturer license", medical device Product registration certificate;
(b) from the pharmaceutical wholesalers, medical equipment business enterprises for the first time the procurement of drugs, medical equipment, should check the "Drug License", drug approval documents or "Medical Device Business License", medical device product registration certificates;
(c) the procurement of imported medicines, should be checked for documents of approval of the import of drugs and imported Inspection quality report; procurement of imported medical devices, should check the medical device import registration certificate, import quality inspection requirements, should also check the import inspection quality report. Article VIII of the medical institutions on the purchase of drugs and medical devices should be batch by batch acceptance, and make records.
Medical institutions to accept donations, gifts of medicines and medical equipment, from other medical institutions to transfer the need for first aid medicines and medical equipment, or from the drug retailers directly purchased first-aid need for medicines, should be in accordance with the provisions of the preceding paragraph for acceptance, and make a record. Article IX of the drug acceptance record shall include the generic name of the drug, specifications, batch number, expiration date, manufacturer, supplier, quantity purchased, purchase price, date of purchase, date of acceptance, acceptance of the conclusion and so on.
Medical device acceptance records should include the product name, specifications, product lot number (date of manufacture), manufacturer, supplier, purchase quantity, purchase price, purchase date, acceptance date, acceptance conclusion and other content; there are sterilized batch number, expiration date, should be recorded as a sterilized batch number, expiration date; medical instruments, equipment acceptance records should also include relevant configuration and technical indicators.
Acceptance inspection records signed or stamped by the acceptance of personnel, filed and preserved. Acceptance records and related vouchers should be kept for at least 3 years; there is a product expiration date, it should be kept until more than 1 year product expiration date. Article 10 The village health office (office), community health service center (station) and other medical institutions from the drugs, medical equipment production or operation of the enterprise procurement of drugs and medical devices have difficulties, can be entrusted to other medical institutions on behalf of the procurement. Entrusted procurement agreement shall be filed with the county-level food and drug supervision and management department.
Encouragement of drugs, medical equipment business enterprises directly to the medical institutions to distribute drugs, medical equipment. Article XI of the medical institutions should be set up with its size of the pharmacy (pharmacy). Pharmacy (pharmacy) should be separated from the living, office and medical areas, and have the necessary light, ventilation, insect-proof, rodent-proof conditions, as well as temperature and humidity control equipment.
Hospital-type medical institutions should be set up to store drugs, medical equipment, cold storage (cabinet), cool storage. Non-hospital medical institutions should be set up according to the need for cold storage (cabinet), cool storage, and as far as possible to shorten the storage period of drugs, medical equipment. Article XII of the medical institutions should be in accordance with the product specification marked storage conditions for drugs, medical equipment, and monitoring and recording of the temperature and humidity of the storage area.
Medical institutions to store medicines, medical devices to implement color-coded management, classification and storage. Easy to string of drugs, Chinese herbal medicines, Chinese medicine should be stored separately from other drugs; expired, deteriorated, expired and other unqualified drugs, medical devices should be placed in the unqualified library (area).