(October 17, 2006, Liaoning Provincial people's Government, the 64th Executive meeting on November 14, 2006, 197th promulgated by the people's Government of Liaoning province as of December 1, 2006) first in order to strengthen the hospital drug management and supervision over the use of medical devices, protection of human health and safety, protect legal rights of patients, according to the People's Republic of China pharmaceutical administration law of the supervision and administration of medical devices Ordinance and the State Council and other relevant laws and regulations,
Combined with the province, these measures are formulated.
Article the province within the administrative area of medical institutions ' use of medicines and medical instruments (hereinafter referred to as controlled drugs) should abide by these measures.
Special management of narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive pharmaceuticals supervision and management, in accordance with the relevant provisions of the State.
Article province food and drug administration and the food and drug regulatory agency (hereinafter referred to as the food and Drug Administration) is responsible for the supervision and administration of medical institutions ' use of insecticide in their administrative areas.
Article fourth medical institutions rather than adapt to the size of the medical device regulatory agencies should be set up or designate qualified personnel responsible for medical device management, protection of machinery safety, prevent sudden groups the incidence of adverse events in controlled. Article fifth direct contacted with drugs in medical institutions and personnel of sterile medical devices, should health examinations every year and setting up health records.
Suffering from infectious diseases, and other potentially contaminated drugs and diseases of sterile medical devices staff, healing or to exclude possible pollution before, may not engage in direct contact with the pharmaceuticals and sterile medical devices work.
Sixth article medical institutions should established following management system: (a) machinery procurement acceptance; (ii) machinery out storage review; (three) machinery quality problem report and bad reaction (event) of monitoring and report; (four) drug deployment and review and the drug custody conservation; (five) drug validity monitoring; (six) preparations of preparation, and custody and using; (seven) medical devices using and maintenance maintenance; (eight) implanted sex medical devices quality track; (nine) one-time using of no bacteria medical devices with Hou destroyed.
For more than two (including the grade) medical institutions for the matters prescribed in the preceding paragraph should be introduced for computer management.
Article seventh medical institutions must have drug production or wholesale license purchasing medicines.
Clinics, health clinics in rural areas, can be qualified pharmaceutical wholesale distribution center and its local distribution point of purchasing drugs; there is difficulty in directly purchasing, you can delegate local township (town) hospitals in purchasing.
Purchase of township (town) hospitals should be signed with the principal responsibility for the quality of the agreement, and these measures are in accordance with the relevant provisions of that purchase, shall not in any name to go by other units or individuals to purchase drugs.
Eighth medical institutions shall be determined by the medical device regulatory agencies unified procurement, management of medicines or a designated individual, and keep to prove drug purchasing information about vouchers, drug procurement files.
Drug procurement archives should including supply party provides of following information: (a) drug production or drug wholesale business license and license of copies; (ii) drug production or business quality management specification certification certificate of copies; (three) imports drug registered card or medicine products registered card and imports drug test report book, and imports drug documents, drug approved file of copies; (four) biological products test proved file of copies;
(E) pharmaceutical sales unit of authorization or power of Attorney and their identification.
The preceding paragraph (a) to (d) provides copies of the information, shall be affixed to provide unit seal.
Nineth medical agencies shall purchase the lot number of the drug, lot-by-lot inspection against purchase drugs, in addition to verify proof of qualifications and relevant drug supplier, but also examine drug appearance, packaging, labels, instructions, and fill in the real and complete drug acceptance record.
Drug acceptance record shall include the drug's generic name, dosage form, specifications, batch number, production date, expiry date, manufacturers, suppliers, purchase order number, purchase price, purchase date, the acceptance of the conclusion and signature of acceptance. Pharmaceutical inspection record storage time shall be not less than 3 years.
Drugs are valid for more than 3 years, drugs acceptance record-keeping time is 1 year after the expiry date of the medicine.
Tenth Article medical institutions procurement of Chinese herbal medicines, its each pieces packaging Shang should marked name, and supply units name, and origin, and number, and harvest (processing) date; procurement of medicine pieces, its each pieces packaging Shang should marked name, and specifications, and origin, and production enterprise, and products batch, and production date,; procurement implemented approved paper, management of Chinese herbal medicines, and medicine pieces, its packaging Shang also should indicate approved paper,.
Chinese herbal medicine, Chinese medicine pieces packaging does not meet the provisions of the preceding paragraph, the medical institution shall not purchase.
11th drug storage and administration of medical institutions, according to the medicine quality control specifications of the relevant provisions of the State.
12th medical institutions shall be authorized by law in diagnosis and treatment of subjects or services within the scope of the project to use drugs. 13th medical institutions should strictly enforce the validity of drug monitoring and management system, regularly carry out expired drugs inventory.
On expiry of medicines, you must immediately stop using and in accordance with the relevant regulations. 14th medical institutions must be based on the medical doctors prescribing to patients with deployment medicine.
May not be operating or free clinic, Bazaar, advisory services, probation, marketing, mailing, gift means such as drugs.
15th medical institutions in drug dispensing and packing establishments, facilities, tools, packaging materials, and should meet the quality and hygiene requirements. On the packaging of the drug shall make a record.
Packaging shall be indicated on the packaging of drugs after drug name, specifications, batch number, dosage, use, contraindications, validity, etc.
Article 16th medical institutions to purchase medical equipment, medical device manufacturing enterprise license or medical device distributing Enterprise license permits the production, within the registered product.
Medical agencies shall not purchase and does not meet national standards, industry standards and register product standard for medical devices.
17th medical institutions shall be determined by the medical device regulatory bodies or designated officer uniform procurement of medical equipment, and keep to prove medical device purchasing information about vouchers, medical equipment procurement files.
Medical devices procurement archives should including supply party provides of following information: (a) medical devices production enterprise or business enterprise license, and license of copies; (ii) medical devices registered card (containing annex) and other proved file of copies; (three) national provides detection of medical devices products detection report (contract products batch) of copies; (four) medical devices products certificate Ming; (five) medical devices sales personnel of units authorized or Attorney and identity proved.
Provision of the preceding paragraph (a), (b) and (c) provide copies of information, providing unit seal shall be affixed to it. 18th medical organizations purchasing medical equipment quality check should be carried out.
In addition to verify for credit qualification and certification documents, should also fill out the acceptance record is true and complete.
Medical device inspection record including product names, manufacturers, suppliers, model, product number, production date, batch number (number, serial number), sterilization lot number, expiration date, registration number, packaging, date of acceptance, acceptance of the conclusion and signature of acceptance. Medical device inspection record shall be kept until the expiry or to stop after 1 year, but not less than 3 years.
Implantable medical device inspection record and quality track record of saving over the same period. Article 19th before using medical equipment of medical institutions, shall, in accordance with the relevant regulations by routine quality checks. Before the use of sterile medical devices, direct contact packaging for medical devices and should be valid for a routine check.
Damaged packaging, labeling is not clear, expired or may affect safe and shall not be used.
20th medical institutions use of implantable medical devices, shall establish a true and complete quality track record.
Quality track records of content including Department name, and patients name, and gender, and age, and address, and communications address, and contact phone, and hospital,, and surgery time, and surgery who, and products name, and products number, and specifications model, and production Enterprise name and the registered address, and origin, and production enterprise license,, and medical devices products registered card,, and products coding (serial number), and production date, and production batch, and validity, and supply units, and supply units license,, necessary of products track information.
Quality track record should be included in the patient medical record management.
Article 21st for diagnostic and therapeutic medical devices, medical institutions should be carried out in accordance with the relevant provisions of the medical device management inspection, repair and maintenance, and to establish a regular inspection and maintenance and maintenance records.
Records should include Department, device name, registration number, specifications, manufacturing plant, the factory time, activation time, inspection and maintenance time, test and repair, inspection and maintenance unit, inspection and maintenance of the project results.
Medical devices for diagnosis and treatment of clinical safety and effectiveness is not assured, you must immediately stop using. 22nd places for storage of medical equipment of medical institutions, facilities and conditions shall conform to the quality and safety of medical devices needed.
Specific management measures shall be formulated separately by the provincial food and drug administration.
Article 23rd medical institutions not for profit will be the failure of the second class and class III medical devices sold for sale to other medical institutions using medical institutions shall not receive other medical institutions have lost their second class and class III medical devices. In addition to imports and abroad which are used outside of large medical equipment medical equipment, medical institutions using the class II and class III medical device, set up by the provincial food and drug supervision and management departments of qualified medical device inspection inspection fail failure, free gifts or in accordance with national and provincial transfers the relevant provisions used in other medical institutions. When the Parties shall sign an agreement and the transfer of medical records.
24th article food drug supervision management sector should on medical institutions of following matters for supervision check, medical institutions should truthfully provides situation and corresponding information, shall not refused to and hide: (a) machinery management institutions or personnel of set and about personnel of health check situation; (ii) machinery management system of established and implementation situation; (three) machinery procurement and acceptance records, archives information of management situation; (four) drug points loaded, and deployment and preparations preparation, and save, and using situation; (five) machinery conservation, and maintenance, and
Store and update system replaced conditions.
25th food and drug supervision and management departments of medical institutions when conducting supervision and inspection, may exercise the following powers: (a) the extracting machinery samples tested, (ii) identification of the medical institution purchases of machinery instruments and related credentials such as books and (iii) to take compulsory administrative measures and (d) other functions and powers prescribed by laws and regulations.
Sampling inspection shall not charge a fee.
26th, established by the food and Drug Administration qualified medical device inspection authority shall, in accordance with national regulations and related standards, implement sampling inspection of medical devices for medical use, and a survey report.
Provincial food and drug supervision and management departments should be based on actual needs, preparation of annual sampling plan and supervise the implementation of published medical device quality supervision announced to the public on a regular basis. 27th food and drug supervision and management departments should be the establishment of credit management system of medical institutions. On violation of controlled medical institutions shall record into the computer management system of medical institutions in credit.
Refused to correct medical device using illegal medical institutions can be announced to the public.
28th food and drug supervision and Administration Department shall establish a reporting system for machinery used in medical institutions, social telephone hotlines. 29th medical institutions in the procurement and acceptance, the use of medical devices found during its safety and effectiveness there are serious quality problems should be sealed on the spot and immediately reported to the food and drug administration.
Food and drug administration after receiving the report, shall be lawful investigation and handling. Article 30th food and drug supervision and management departments should establish machinery group bad emergency plans.
Food and Drug Administration adverse event reports received a controlled emergency groups shall promptly start emergency plans to ensure public safety.
31st article medical institutions has following case one of of, by food drug supervision management sector ordered corrected, give warning, can and at 500 Yuan above 1000 Yuan following fine: (a) not by this approach provides established machinery management system of; (ii) directly contact drug and no bacteria medical devices of personnel, not for health check and established health archives of; (three) with infectious diseases and the other may pollution drug and no bacteria medical devices of personnel, engaged in directly contact drug and no bacteria medical devices work of;
(Four) machinery store not meet national and province about provides of; (five) not established machinery procurement archives or procurement machinery no acceptance records, and records content not real, and full of; (six) points loaded Hou of drug packaging not meet provides of; (seven) not regularly for expired drug inventory of; (eight) using implanted sex medical devices not do quality track records or records not real, and full of; (nine) occurred medical devices bad event not timely report of; (10) refused to provides machinery archives information and related voucher of;
(11) found that procurement of medical device quality problems, refusing to report or not to seal.
Medical institutions not complying with the reporting of adverse drug reactions, and processed by the administrative departments of public health.
32nd medical institutions for patient allocation, using expired medicines, by the food and drug supervision and administration in accordance with the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law of relevant provisions of the regulations for the implementation of penalties.
Article 33rd medical agency procurement of medical devices and the use of expired or invalid, by the food and drug supervision and administration in accordance with the relevant provisions of the regulations on supervision and administration of medical devices shall be punished. 34th article medical institutions has following case one of of, by food drug supervision management sector in accordance with People's Republic of China drug management method about without license business drug of punishment provides give punishment: (a) beyond law approved of clinic subjects or service range to patients deployment drug from profit of; (ii) not according to this medical institutions physician prescription to patients deployment drug from profit of; (three) Xiang (town) hospitals not and delegate party signed quality responsibility agreement purchasing drug,
Quality responsibility agreement signed or transferred from other units, individual purchase of drug profits; (d) clinic, Bazaar, advisory services, probation, fairs, mail, gifts and other means to sell drug profits.
35th medical organizations for profit will be the failure of the second class and class III medical devices sold for sale to other medical institutions, by the food and drug supervision and administration in accordance with the supervision and administration of medical devices Ordinance relating to the absence of penalties penalties for licensed medical devices.
36th medical institutions never has a production or wholesale business licenses of enterprises in the procurement of drugs, in accordance with the People's Republic of China related to drug management law provides for penalties.
37th medical institution in violation of the regulations, are suspected of the crime, by the food and drug administration handed over to judicial organs shall investigate the criminal damage caused to a party, he shall bear civil liability.
38th article food drug supervision management sector and test institutions staff has following case one of of, law give administrative sanctions; has crime suspected of, law held criminal: (a) received reported or medical institutions machinery quality problem report not timely law processing, caused bad consequences of; (ii) received machinery burst sex groups bad event report not timely started emergency plans, caused bad consequences of; (three) issued false test, and detection report or illegal charged costs of;
(D) participation in the machinery purchase and sale activities; (e) other acts of abuse, malpractice, neglect their duties.
39th class II medical devices in these measures refers to the safety and effectiveness of medical devices should be controlled.
Class III medical device, refer to implanted; to support, maintain life; potentially dangerous to the human body, on the safety and effectiveness of medical devices must be strictly controlled.
Outdated medical equipment, refers to the period in excess of the medical device user's manual or packaging, the validity indicated on the label of class II and class III medical devices.
Failure of medical devices, is not in line with national standards, industry standards or register product standard, cannot guarantee the safety and effectiveness of class II and class III medical devices.
40th these measures shall come into force on December 1, 2006.