Huainan Medical Medical Equipment Supervision And Administration

Original Language Title: 淮南市医疗机构医疗器械监督管理办法

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(May 28, 2007 Huainan municipal people's Government at the 31st Executive session on May 30, 2007, 107th Huainan city people's Government promulgated as of July 1, 2007) first to strengthen the supervision and administration of medical institutions in medical devices to ensure medical device using safe and effective under the supervision and administration of medical devices regulations, combined with the city's actual, these measures are formulated.
    Second medical institution within the administrative area of the city purchase, storage, use, supervision and administration of medical devices, and procedures apply.
    Article city and County Food and drug supervision and management is responsible for the supervision and administration of medical institutions in medical devices within the administrative area.
    Relevant administrative departments within the scope of their respective duties, is responsible for the supervision and administration of medical device-related work in medical institutions.
    Article fourth medical institution shall establish a medical device regulatory agencies or medical device management staff, this unit is responsible for management of medical devices, establishment of medical equipment files.
    Fifth medical institutions shall establish and implement medical equipment purchased, acceptance, storage, use, maintenance, disposal, substandard medical equipment and destroyed after use single-use sterile medical devices management systems, and related records. Article sixth purchase medical equipment of medical institutions shall carry out inspection and acceptance, the legal qualification of suppliers to verify and save the information.
    Acceptance includes product names, specifications, types, quantity, manufacturer, supplier, registration certificate, certification, production date, batch number, sterilization lot number, period of validity, date of purchase, and so on.
    Food and drug supervision and management departments should be on the legality of medical institutions to buy the medical products provides advisory services and other related content.
    Article seventh medical institution shall, in accordance with the instructions of medical devices medical devices, shall not purchase, use, importing medical devices without a user manual.
    Article eighth of medical institutions in incoming inspection, storage, using link in the suspected failed medical devices shall be statutory testing organizations testing of medical devices in time, failed to pass the examination shall not be used, and timely reports to the food and drug administration.
    Nineth storage partitioning, classification should be made for medical equipment store, equipped with shelves and the corresponding pad, moisture-proof, pest control, prevention, fire protection, ventilation, light facilities, need to be kept cold, cool and other special requirements for medical devices, should be required to store. Article tenth medical use of large medical equipment medical equipment file should be established.
    Archive includes equipment inventory, records and maintenance test record; equipment inventory includes used Department, device name, manufacturer, suppliers, specifications, medical device manufacturing enterprise license number, medical device registration certificate number, certificate, purchase price, delivery time, activation time, status, and other. 11th medical organizations used by the other medical institutions or medical device manufacturing enterprises once again transfer, sale, grant has used medical devices, shall be filed with the food and Drug Administration for record, and tested prior to use.
    Does not meet performance requirements, shall not be used. 12th medical institutions using orthopaedic internal fixation devices, cardiac pacemakers, intravascular catheters, artificial Crystal, a stent implanted medical devices, shall conform to the relevant regulations of the State, establish and maintain detailed records. Records include Department name, patient name, sex, age, length of hospital stay, bed number, duration of surgery, surgery, product name, product number, specification, manufacturers name, medical device manufacturing enterprise license number, medical device registration certificate number, product number, production lot number, business unit, business license number, expiration date and other necessary products tracking information.
    Record retention period should be at least more than 1 year after the termination period.
    13th article prohibited the use of unregistered, no certificates, expired, invalid or obsolete medical equipment.
    Medical devices that have been implanted, without registration, no certificates, expired, invalid, or out of, the medical institution shall promptly inform the patient and be replaced for free; no Exchange should be free to patients on a regular basis to check; patients caused personal injury, shall bear civil liability.
    14th medical device quality accident in medical institutions, medical device adverse event shall promptly report to the food and drug administration and health administration. 15th food and drug supervision and management departments should strengthen the supervision of medical institutions in medical device inspection and inspection, to announce the test results on a regular basis.
    Selective testing of medical devices, shall not charge a fee.
    A medical institution shall meet the supervision of food and drug supervision and Administration Department shall implement inspections and inspection work.
    16th medical institution in violation of the article fifth, sixth paragraph, Nineth and tenth, 11th and 12th articles, by the food and Drug Administration ordered corrected; fails to make corrections, and fined 1000 Yuan fine.
    Article 15th 17th violation to these measures, refused the supervision and inspection of medical institutions, providing false information or omission of circumstances, by the food and Drug Administration fined 1000 Yuan fine.
    18th medical institutions violating other provisions of these measures, by the food and drug supervision and administration in accordance with the regulation on supervision and administration of medical devices, such as rules and regulations shall be punished.
    19th staff of the food and drug administration and its neglect, abuse, deception, shall be given administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
                                20th article of the rules take effect on July 1, 2007.