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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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(The 31st ordinary meeting of the Government of the Turkmen Republic of 28 May 2007 considered the adoption of the Decree No. 107 of 30 May 2007 No. 107 of the Decree No. 107 of the Government of the Turkmen People's Republic of Mauritius, which came into force on 1 July 2007)

Article 1 ensures the safe and effective use of medical equipment, in accordance with the Medical Assurance Regulation, and develops this approach in the light of the actual practice of this city.
Article 2
Article 3 provides for the supervision of medical institutions in the present administration, in the city, in the district food medicine surveillance administration.
Within their respective responsibilities, the executive branch is responsible for the management of the medical agency medical equipment.
Article IV. Medical institutions should establish medical equipment management or be equipped with medical personnel, responsible for the management of medical equipment in this unit, and establish medical equipment files.
Article 5 Medical institutions should establish and implement systems such as the acquisition, inspection, storage, use, maintenance, debriefing, non-qualified medical treatment and the destruction of unbirable medical devices after the use of sterilized medical devices.
The acquisition of medical equipment by medical institutions shall be subject to inspection and verification of the legal qualifications of the supply unit and the preservation of the relevant information. The receipts include product names, specifications, stereotypes, quantity, production enterprises, supply units, registration certificates, eligible certificates, date of production, production of bribes, effective periods, acquisition date.
Food drug surveillance authorities should provide advisory services on the legal aspects of the acquisition of medical institutions for the acquisition of medical equipment products.
Article 7. Medical institutions shall use medical equipment in accordance with a medical note and shall not procure, use imported medical equipment without a written statement.
Article 8. Medical institutions are suspected to be non-qualified medical devices in connection with the acquisition, storage, use, etc., and should be provided in a timely manner to the medical-care body for the testing of the legal inspection body, which is not qualified, and reports to the food drug surveillance authorities in a timely manner.
The storage of medical equipment should be carried out by sub-regional, disaggregated storage, with corresponding mattresses, cargoes and trajectorys, defence of rats, fires, ventilation, sensors, etc., and medical equipment requiring special requirements such as refrigeration, vouchers should be stored as required.
Article 10 The use of large medical equipment by medical institutions should establish medical equipment files. The archives include the equipment desk, the use of records, maintenance of maintenance inspection records, etc.; the contents of the equipment desk, the name of the equipment, the production plant, the supply unit, the specifications, the medical equipment's licence for the production of the enterprise, the medical certificate of the weapon, the qualification certificate, the purchase price, the time taken, the start of the operation, etc.
Article 11. Medical agencies use the re-transfer, sale, licensed medical equipment used by other medical agencies or medical devices, which should be backed by food drug surveillance management and tested before use. Inadequate access is not required.
Article 12 Medical institutions use stereotyped equipment, carboys, blood pipes, manuals, tenets, etc. in the human body, and should be in line with national provisions to establish and maintain detailed records of use. The records include the name of the section, the name of the patient, sex, age, hospitalization, beds, the time of operation, the name of the product, the number of products, the specifications, the production of enterprise name, the licence for the manufacture of medical devices, the registration of medical equipment, the product number or the production of the whole, the operating unit, the operating permit number, and the necessary product tracking information. The duration of the record should be at least one year after the end of the use period.
Article 13 prohibits the use of unregistered, unqualified, expired or phased medical devices.
Medical equipment that has been pushed into human beings, without registration, qualifications, expires or phase-out, medical institutions should notify patients in a timely manner and replace them free of charge; no replacement should be carried out on a regular basis for the patient's free examination; and the infliction of physical harm on the patient, with corresponding civil responsibility under the law.
Article 14. Medical institutions have experienced accidents in the quality of medical equipment, inadequacies in medical equipment, and should report in a timely manner on food drug surveillance management and the health administration.
Article 15. Food drug surveillance management should enhance surveillance and screening of medical equipment and regularly inform the findings of social announcements. The screening of medical equipment is not charged.
Medical agencies should cooperate with the supervision and screening of food medicine surveillance exercises carried out by the Food Drugs Monitoring Administration under the law.
In violation of article 5, paragraph 1, article 6, article 9, article 9, article 10, article 11, article 12 of the scheme, the time limit for the supervision of food medicine is changed; the impending failure is fined by 1000.
Article 17, in violation of article 15 of this approach, provides that medical institutions refuse to monitor the inspection or conceal the relevant information, provide false information, and are subject to fines of up to 1000 dollars for food drug surveillance authorities.
Article 18 Medical institutions violate other provisions of this approach and are punished by regulations, regulations and regulations, such as the Food Drugs Control Regulation.
Article 19 Food drug surveillance authorities and their staff play roles, abuse of authority, provocative fraud, are subject to administrative disposition by law, which constitutes an offence and are criminally prosecuted by law.
Article 20