Key Benefits:
(Summit No. 47th Standing Committee of the People's Government, 2 March 2006, considered the adoption of Decree No. 147 of 7 April 2006 of the People's Government Order No. 147, dated 1 June 2006) Article 1 ensures the safety of people's health-care providers in order to strengthen the monitoring management of the use of medicines and to develop this approach in line with the National People's Drug Management Act, the Medical Assurance Regulation and related provisions. Article 2, this approach applies to the supervision of medical equipment use units and their medical equipment in the city's administration. Article 3 The use of pharmaceutical medical equipment means acts such as procurement, storage, distribution and use. Article IV oversees the management of surveillance of the use of medicines medical equipment in the city. The district-level food drug control surveillance management is responsible for the supervision of the use of pharmaceutical-care equipment in this jurisdiction. The sectors such as health, business administration, quality technical supervision management are responsible, within their respective responsibilities, for work related to the use of medicines. Article 5 (i) Accredited pharmacologists and medical equipment or related professional technicians under the law; (ii) Facilities, equipment, warehousing facilities and sanitation environments that are adapted to the use of medical equipment; (iii) Quality management or personnel that are adapted to the use of medical equipment; (iv) Regulations that guarantee the quality of the medical equipment used; (v) Persons who are directly exposed to medicines, one-time use of sterilized medical devices shall be eligible for health checks; (vi) Other conditions set forth in laws, regulations and regulations. Article 6. The following acts are prohibited by the pharmaceutical-care unit: (i) A record of the purchase of a counterfeiting medical equipment; (ii) The operation or conversion of drug medical equipment, such as mail, patient, counselling, clinical probation; (iii) Bring medical diagnostics for the sale of medical equipment; (iv) Other prohibited sexual acts under laws, regulations and regulations. Article 7. Article 8. The drug use units shall be produced from pharmaceutical products with a licence for the production of medicines or a licence for the operation of the pharmaceutical industry and the license of the operation, the operation of the manufacturer to procure drugs within its production and operating licence. Medical devices should be produced by medical equipment with a licence for the production of enterprises for the manufacture of medical equipment or a licence for the operation of a medical facility and a licence for business, the operation of an enterprise to procure its production and the medical equipment within the scope of the licence (other than medical equipment that does not apply for the licence management). Article 9. The procurement of medicines, medical equipment and equipment by medical equipment units must be in place and strictly enforced, the acquisition of medicines, medical devices should be made on a case-by-case basis, recorded, and the creation of relevant files, the identification of the legal qualifications, the quality of products and the marking. The data collection of medicines is recorded in accordance with the relevant national provisions. The inspection records of medical equipment include the production of enterprise name, product name, specifications (referrals), production of the number (releading factor), effective periods, registration certificates, supply units, procurement prices, procurement dates, procurement dates, inspection personnel etc. The record of the medical check-up should be true and kept for more than two years. Article 10 Medical equipment is granted by grantees, donations of medicines, medical equipment and equipment, which shall be reported in the food drug surveillance management at the location of 5 days prior to the use of the food medicine surveillance system, and the food drug surveillance authorities shall conduct inspection, written replies within 10 days of the date of receipt of the report, with the exception of the law. Special circumstances such as natural disasters, sudden public incidents are carried out in accordance with the law. Article 11 Stockpiles of medicines, medical devices should be in accordance with the statutory standards and classified. Unqualified medicines, medical devices should be stored separately in specific regions, marking norms; storage of medicines, medical devices or facilities should be in line with the conditions of circumventation, ventilation, temperature testing and regulation, dust, resistance, pollution prevention, pest and ratification. Article 12. The drug use unit shall conduct regular inspections of the pharmaceutical products of this unit and keep the records of the inspections; unqualified medicines that have been identified, tested and published in quality notices should be stored in a timely manner, and registration of names, specifications, doses, production units, effective periods, quantity, freight values, etc. shall be carried out in accordance with the approval of this unit, be sent to the host food surveillance management case; non-qualified medicines deposited with the drug use units shall not be processed without the authorization of the authorities to monitor the destruction of foods at the disposal sites. Article 13 quantification of drugs should be strictly enforced and should not be used for the purposes of drug control. Article 14. Article 15. When drug use units, the pharmaceutical retailer manufacture is tiny, they shall not be pre-emptive, equipped, codified, codified or replaced. Article 16 Medical equipment use units should establish a system for the use of medical equipment for the use of descriptives, end-of-trajectives, failures, rehabilitation of schools are not standardd, direct contact with non-products registration certificates, and direct access to food-free medical equipment should be discontinued and the medical treatment of the medical facility should not be carried out at the end of the use of the medical facility's name, the specifications, the number or place of plants, the production units, the quantity, the value of deliveries, etc. The destruction of medical equipment was determined by the municipal food drug control surveillance authorities, which should be monitored by the food medicine surveillance authorities in a timely manner, and after-removal medical devices could be processed on their own. Article 17 Medical equipment use units should follow up on the use of vegetation medical equipment, establish archives, including the names of patients, contact telephones, hospitalizations, time of operation, names of veterans, the name of the vegetation, the name of the manufacturer, the specifications, the number of plants, the product registration certificate, the production plant, the tracking of the record, and the history of the disease. The archives are kept permanently. Food drug surveillance authorities should use inputs and should be controlled to ensure safety and effectiveness of medical equipment and regularly evaluated. The evaluation was not qualified and the use of units was tasked with rehabilitating medical equipment, and the results were reported to the food medicine surveillance management. Eligible parties can be used and implemented in accordance with article 16 of this approach, as the standards are not met. Article 19 Food drug surveillance authorities should destroy the confiscated vacious medicines, the pseudoephious medical products on a regular basis. The destruction of false medicines, falsely falsely malicious medical products should be registered, the completion of the list of items destroyed and approved by the head of the Food Drugs Monitoring Administration. The registration form, the list of items destroyed is maintained. Article 20 Food drug surveillance authorities should develop quality management norms for the use of medicines, quality management of the use of medical devices and publicize implementation after approval by the municipal authorities. Article 21, the Illicit Drug Control Monitoring Administration should establish a system for the evaluation of drug, medical equipment use units, the development of evaluation standards and the conduct of evaluation of pharmaceutical, medical and equipment-use units, which should be indicative. Article 22 Food drug surveillance authorities should perform oversight functions and conduct monitoring inspections, including through regular inspections, routine inspections, special inspections and follow-up inspections. Article 23: Food drug surveillance authorities shall carry out monitoring inspections in accordance with the following procedures: (i) Identify oversight elements and programmes and inform them; (ii) Organizing oversight; (iii) A report on the results of oversight; (iv) The law of the offence and the organization of investigations; (v) To inform the supervisor of the findings and the decisions taken; (vi) Transfer of the relevant sector by functional division of labour, subject to review; (vii) Implementation of the decision to monitor the handling of inspections and the relevant information shall establish the archives. Article 24: Food drug surveillance authorities have relevant laws, policies, regulatory information on new legislation, the introduction of a regular publication system, the establishment of information dissemination networks and the publication of them in municipal newspapers. Article 25. When food drug surveillance authorities carry out monitoring inspections, the drug medical equipment use units should be proactively coordinated, such as the provision of samples, documents, archives and information related to the identified matters, without denying concealment. Article 26 Civil, legal or other organizations have found that drug, medical equipment and equipment use units are in violation of the provisions of this approach, and have the right to report or complain to the food drug surveillance authorities, to receive reports or complaints, and to investigate and verify that the law is dealt with. The twenty-seventh Pharmaceutical Unit does not provide warnings for the implementation of the quality management norms for the use of medicines, the quality management of the use of medical devices, the correcting of the deadline, and the imposition of fines of up to $3000 million in excess of 200 million. The twenty-eighth drug medical equipment use unit does not register and track the use of intrusive medical equipment, and is warned by the location's food medicine surveillance management and corrective. Article 29, Staff members of the Food Drugs Monitoring Authority are toys, abuse of authority, provocative fraud and administrative disposal; constitute crimes and hold criminal responsibility under the law. Article 33 |
