Key Benefits:
(Act No. 56 of 7 February 2006 of the Order of the People's Government of Chiborbo, effective 1 March 2006) Article 1 ensures the safety, effectiveness and effectiveness of medical equipment, in line with the State Department's Medical Assurance Regulation, and develops this approach in conjunction with this city's practice. Article 2 Article 3. Medical institutions referred to in this approach are those established by law to use medical equipment such as disease prevention, diagnosis, treatment, health-care activities, family planning technology services and other health prevention, sanitation, medical science and technology. Article IV regulates the supervision of medical equipment in the city, district and district drug control authorities responsible for the management of medical equipment in the current administration area, in accordance with their regulatory authority, and does not establish a zone in which the food medicine surveillance management is in charge of the supervision of the medical equipment of their medical institutions. Sectors such as health, population and family planning, quality technical supervision should be able, within their respective responsibilities, to oversee the management of medical institutions. Article 5 Medical institutions should establish medical equipment and medical equipment accounts, strengthen the management of medical equipment and guarantee the safety and effectiveness of medical equipment. The use of medical equipment by medical institutions should be registered in the district food medicine surveillance management. The registrations include the names of medical institutions, addresses, representatives of legal persons, heads, medical equipment registration categories. The content of the registration is changing, and the health agencies should inform food drug control oversight management in writing within 30 days of change. Article 7. Medical institutions should establish medical equipment management or be equipped with medical personnel for the management of medical equipment in this unit. Article 8. The use of medical equipment by medical institutions should have the corresponding technical and environmental conditions. Article 9. Medical institutions should establish and implement systems of acquisition, inspection, storage, use, maintenance, poisoning, reporting and disposal of medical equipment. Article 10 Medical institutions shall verify the legal qualifications of medical equipment units and preserve relevant information. Article 11. The acquisition of medical equipment by medical institutions should be conducted in quality. The receipts include: product name, specifications, stereotypes, production enterprises, supply units, registration certificates, medical devices registration forms, prequalification, date of production, production of bribes, effective period and date of purchase. A quality inspection record should be completed after the receipt, with the confirmation being retained upon signature by the recipient. Medical equipment to be certified by compulsory products or managed by a licensed directory of industrial products should also include compulsory product certification or industrial product production licences. Article 12. Medical institutions shall use handicrafts for re-use of medical equipment and shall be inspected or validated prior to the use of medical equipment and not required for the use of medical equipment. Article 13 Medical agencies purchase more than 300,000 medical equipment worth, and the management of food medicine surveillance in the veterans' products legally certified material. Food drug surveillance authorities should provide advisory services on relevant elements such as the legitimacy of medical equipment products. Article 14. The storage of medical equipment should be carried out by subsectors, by classification, with mattresses, loads, and trajectorys, defence, fire, ventilation, and access to light facilities. Article 15. The use of a one-time use of unbirable medical equipment by medical institutions should be consistent with the relevant provisions of the State to establish acquisitions, release, recycling, poisoning and destruction records. There are poisoning, destruction facilities and access to waste. A one-time use of sterilized medical equipment, which is included in the centralized disposal of medical waste, should be handled directly by the medical waste concentration disposal unit. The use of medical equipment in the vegetation system should be consistent with the relevant provisions of the State, the establishment of a specialized custodian, the establishment of an acquisition, inspection, issuance of records. Accreditation of products, a registration certificate and a copy of the medical-armed registration form should be kept together with the disease. The use of large-scale medical equipment by medical institutions should establish medical equipment, maintain records, and use and maintain records should be properly maintained. Article 18 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 health-care systems. Article 19 has already resulted in a medical accident or a safely hidden medical equipment and related information, which can be sealed and seized by the urban, district and district food drug surveillance authorities. Article 20 of the medical body found that the quality was suspicious during the use of medical equipment, the use should be suspended, the timely transfer of medical equipment tests and the reporting of food medicine surveillance authorities. Article 21, the medical body shall phase out the medical equipment value of more than 300,000 dollars, and shall include the name, specifications, stereotypes, the use of annual limits, and the management of food medicine in the reporting area. Article 2 Medical institutions that undertake clinical probationary or clinical accreditation of medical equipment should comply with the relevant national provisions to provide authentic, complete clinical trials or clinical verification reports. Article 23. Medical institutions should establish health files for medical agents. Article 24 Food drug surveillance authorities should strengthen monitoring inspections and inspection tests of medical equipment, and the relevant units and individuals are not denied and concealed. The screening of medical equipment is not charged. Article 25 Medical devices are not qualified by monitoring inspections, screening tests, and medical institutions should immediately cease their use. Article 26 The technical secrets and operational secrets of the inspector known to the inspector in the supervision should be confidential. Article 27, in violation of the provisions of this approach, provides that the law, legislation and regulations contain clear penalties from their provisions. Article 28, in violation of this approach, provides that medical institutions have not been registered in the Food Drugs Monitoring Administration and are subject to a reduction in the time limit for food medicine surveillance management. Article 29, in violation of this approach, provides that a medical institution has one of the following acts and is converted by the time limit for the supervision of food medicine to the management responsible for the maintenance of the order; and is fined by 1000 dollars for the overdue period: (i) The acquisition, inspection, storage, use, maintenance, poisoning, void and disposal of medical equipment; (ii) A record of the acquisition of medical equipment; (iii) A one-time use of unbranted medical devices cannot be equipped with their wastes. In violation of this approach, medical institutions use re-use of medical equipment without detection or verification of the use of inputs, which is discontinued by the Food Medicine Monitoring Administration and fined by $100,000. In violation of this approach, medical agencies use in-house medical equipment to obtain a copy of the certificate of eligibility, registration certificate and medical equipment' registration form and conserving with the disease, which is subject to a fine of $100,000 by the food drug surveillance management for the period of time. Article 32, in violation of this approach, provides that medical institutions are subject to a medical accident of the quality of the medical equipment or to a malmedical incident, without reporting on food drug surveillance management and drug abuse surveillance agencies, with a fine of 500 dollars. In violation of this approach, medical institutions refuse to provide relevant information, with a fine of $50 million from food medicine surveillance management, concealing the information and providing false information, and fines of $100,000 from the food medicine surveillance management. Article 34, in violation of this approach, provides that a staff member of the Food Drugs Monitoring Authority has one of the following acts and is subject to administrative disposition by law; constitutes an offence and is held criminally by law: (i) The finding that the violation is not lawful; (ii) Disclosure of technical secrets and operational secrets known in the inspection; (iii) Injuring the parties or receiving the bribes; (iv) Other acts of negligence, abuse of authority, favouring private fraud. Article 33XV considers that the specific administrative acts of the executive body violate their legitimate rights and interests, may be applied by law for administrative review or administrative proceedings. Article 36 refers to re-use of medical equipment as described in this approach to the use of medical equipment, which has been used by medical agencies or medical equipment, the re- marketing, transfer, grant medical equipment. Article 37 of this approach is implemented effective 1 March 2006. |
