Lanzhou hospital drug and medical device regulatory approach (March 25, 2011 Lanzhou City Government 4th times Executive Conference considered through March 29, 2011 Lanzhou City Government makes 2011 4th, announced since May 1, 2011 up purposes) first article for strengthening medical institutions drug and medical devices of supervision management, guarantee machinery security effective using, guarantees human health and life security, according to People's Republic of China drug management method, and State on strengthening food, products security supervision management of special provides, and
People's Republic of China pharmaceutical administration law regulations for the implementation, supervision and administration of medical devices Ordinance and other relevant laws and regulations, combined with the city's actual, these measures are formulated.
Second medical institution within the administrative area of the city of drugs and medical devices (hereinafter referred to as controlled drugs) purchase, Stockpiling and use of regulated procedures apply.
Mentioned in these measures refers to medical institutions including: disease diagnosis and treatment activities in hospitals and health centers, nursing homes, clinics, clinic, Health Center (room), MCH (standing), community health centers (stations) as well as first aid stations and so on.
Article city and County Food and drug supervision and Management Department (hereinafter referred to as the food and drug administration departments) are responsible for the supervision and administration of medical institutions controlled by the municipal and County.
City and county governments departments concerned shall, within their respective areas of responsibility do medical device supervision and administration of medical institutions.
Fourth medical institutions should be created or a scale suitable for medical device quality management or quality management staff, clear managerial responsibilities, responsible for medical device quality and safety of the unit. Article fifth medical institutions set the pharmacy or medicine cabinet, should conform to standard pharmacy building regulations.
Normalized pharmacy provisions set by the municipal food and drug supervision authorities and the municipal health departments.
Sixth medical institutions shall, in accordance with national, provincial, municipal regulations the units of machinery purchase, Stockpiling and the use of active into the management of remote electronic monitoring system.
Article seventh medical personnel engaged in medical device quality management within the Agency (hereinafter referred to as controlled drugs in China) should be strictly in accordance with the Lanzhou city, pharmaceutical and medical devices industry in supervision and management of seventh, the Nineth and tenth provisions of that article, the 15th.
Article eighth medical institutions should have a legitimate medical device production, management of the enterprise purchased machinery and machinery supply unit qualification testing, set up supplier file; basic drug centralized purchasing essential drugs should be the successful bidder the production, distribution, wholesale purchase.
Nineth medical institutions should obtain the following information when purchasing machinery and with supply unit the original seal:
(A) the supplier license photo copy;
(B) outside machinery enterprises issued by the municipal food and drug supervision Department filing proof;
(C) medical device marketing personnel practising certificates, corporate copy of power of Attorney;
(D) the legal tax bills.
Tenth medical institutions to buy machinery, quality check should be carried out, and establish purchase ledger and is true and complete machinery purchase acceptance record.
Record-keeping to more than machinery for machinery purchased acceptance period or terminating the use after 1 year, but not less than 3 years, in which the implantable medical device to buy the record of acceptance should be permanently stored.
11th medical institutions shall set up medical equipment installation, storage and transit of related records, record keeping to medical devices scrapped after 1 year.
Need professional installation of medical devices, by the manufacturer or its authorized service qualification unit installed.
12th medical institutions to provide patients with the drugs should be commensurate with the scope of diagnosis and treatment, personal settings of outpatient departments, clinics, clinics and other medical institutions shall not be equipped with first-aid medicines and commonly used drugs other than drugs.
Purchase family planning technical service institutions and providing drugs to patients, and approved their terms of service, service projects, operation types for consistent, may not be equipped with essential drug list drugs other than family planning technical service institutions.
Family planning technical service institutions essential drug list by the municipal food and drug supervision authorities and the city's population and family planning departments. 13th medical institutions shall, in accordance with specification store to buy the machinery, and machinery characteristics take refrigeration, freezing, moisture, protected from light, ventilation, fire protection, pest control, prevention and other measures to ensure the quality of machinery.
Medical providers to store machinery must be regular maintenance, and maintenance records.
Conservation check and using in the found quality suspicious of machinery or expired machinery should immediately stop using and sealed, shall not unauthorized returned or destroyed; expired machinery should registration, and report food drug regulatory sector supervision destroyed; expired of anesthesia drug and spirit drug, should report health sector supervision destroyed; quality suspicious of machinery sent test institutions test, test not qualified of, timely report food drug regulatory sector.
14th medical institutions should adopt effective ways to use the device class I medical devices for preventive maintenance, inspection and calibration, and retention of data and records to ensure that devices class I medical devices in good condition.
Medical institutions should be based on medical devices quality management archive.
15th medical institutions shall use licensed physicians or licensed assistant doctors prescription dispensing medicines, prescription-no leveling drugs.
16th medical institutions are allowed to post, open-shelf optional forged prescriptions, over-the-counter and free clinics, charity, counselling, probation, fairs, and other sales or disguised sales of drugs.
Medical institutions shall not up within the Department of pharmacy or medicine cabinet.
17th deployment of drugs in medical institutions of provisioning tools, packing materials, containers, and the working environment shall be sanitary clean, can effectively prevent contamination of drugs. Deployment of drugs requiring the original minimum packaging standardizes, shall make standardizes record and retain the original minimum packaging and drug to drug dispensing have been exhausted.
Standardizes the surface to indicate the name of the drug, pharmaceutical packaging specifications, usage, quantity, batch number, expiry date, name of medical institution and so on.
18th medical institutions shall, in accordance with the requirements of the specification for quality management of pharmaceutical preparations dispensed in medical institutions make medicinal preparations, and on time to the food and Drug Administration Department of remote electronic monitoring system to report medical preparations made, used, inventory.
Medical institutions of the medicinal preparations should publish any advertisements.
19th medical institutions should be made from the drug manufacturing license and certificate of good manufacturing practices certification of pharmaceutical manufacturers to buy the medical oxygen.
Self-made oxygen medical institutions, the equipment used should be made of the registration certificate of medical device products, the production process shall comply with the relevant provisions, the production of oxygen to quality consistent with the People's Republic of China Pharmacopoeia standards.
20th medical devices developed by medical organizations, shall, in accordance with the relevant requirements of quality management for production or processing, production or processing, and the establishment of true and complete record.
Medical institutions to develop medical devices should be used in this unit, it may not be sold to the market, it may not expand the scope of their research and use of medical devices. 21st medical institutions use of implantable medical devices, records should be established, and permanently saved.
(A) the patient's name, address, telephone
(B) the date of surgery, the surgeon's name;
(C) the name, specifications of products (models), registration certificate number, manufacturer, lot number (serial number or serial number), bar code, production date, expiry date;
(D) the supplier, date of purchase, supplier contact address and phone number.
22nd medical institutions must not be used without a registration certificate, a certificate expiration, expired, or in accordance with State regulations on the technology out of the medical device. Article 23rd used medical equipment of medical institutions should be carried out strictly in accordance with the medical device product specification.
Where in the manual or in the package marked "package opened or damaged do not use the" alert medical devices, such as the package opened or damaged do not use.
24th medical institutions such as medical device product manual exaggerated propaganda, false advertising, should be immediately stopped, and promptly report to the municipal food and drug supervision departments.
25th medical organizations use special equipment and included in the national list of compulsory certification of measuring instruments shall be subject to the statutory standards institutes to be used. 26th medical institutions shall, in accordance with relevant regulations of the State, with dedicated staff to this unit using controlled quality, efficacy and adverse effects of tracking.
Finding may be drug or weapon-related adverse reactions or adverse events, should be available to the food and drug administration departments, health department or other relevant departments report.
27th medical institutions shall, in accordance with laws and regulations, strict management of narcotic drugs, psychotropic substances, toxic drugs for medical use, medical use of radioactive drugs, precursor chemicals and vaccines. 28th food and drug supervision departments should strengthen machinery to medical institutions within their respective administrative areas supervisory and inspection, and shall not charge any fee.
Food and drug supervision departments and their staff in the course of supervision of medical institutions, the persons concerned should actively cooperate with and shall not provide false information shall not be refused and hid.
29th medical institution has any of the following circumstances, food and drug regulators ordered by city and county corrections; fails to change, up to 5000 Yuan and 20,000 yuan fine:
(A) in violation of these regulations article fifth, pharmacy or Medicine Cabinet does not meet the standard set of pharmacies to provide;
(B) violation of these measures article sixth, failing to set the unit's medical device purchasing, storage and active into the management of the use of remote electronic monitoring systems;
(C) violation of paragraph II of this article 19th, is not in accordance with the regulations or quality of oxygen produced is incompatible with the People's Republic of China Pharmacopoeia standards;
(D) violation of paragraph II of this article 20th, to market research medical device or development without expanding the use of medical devices.
30th medical institution has any of the following circumstances, the municipal and County Food and drug regulators ordered corrective action and imposed fines of less than 2000 Yuan and 20,000 Yuan:
(A) in violation of these regulations article tenth, not account establishment and acceptance of purchase records and not complying with the requirements to keep inspection records;
(B) violation of these regulations section 11th, failing to establish or retain records of medical devices;
(C) in violation of these regulations article 15th, prescription-free deployment of drugs;
(D) violation of the second paragraph of article 18th, advertisement preparation preparation of medical institutions;
(E) violation of these measures article 21st, implantable medical device has not been established using the record or the record is not complete;
(Vi) violates this article 26th stipulation, not complying with the reporting of adverse drug reactions and adverse events of medical devices.
31st medical institution has any of the following circumstances, food and drug regulators ordered by city and county corrections; fails, fined 500 Yuan more than 2000 Yuan the following fines:
(A) in violation of these regulations under article eighth, failing to establish supplier files;
(B) disobey 13th article, do not store controlled by the regulation or maintenance records and the counterfeit controlled drugs or faulty product returned without authorization, replacement and destruction;
(C) in violation of these regulations article 14th, devices class I medical devices are not in use to retain records or files has not been established.
(D) in violation of this article 17th paragraph, not standardizes records, or do not retain the original minimum packaging and drug and standardizes the packaging surface does not indicate the drug name, specifications, usage, quantity, batch number, expiry date, standardizes medical institution names and other content;
(V) violates the provisions article 24th of this approach, not the municipal food and drug supervision departments dispose of.
32nd medical institutions have one of the following, by the city and County's food and drug regulatory authorities in accordance with the People's Republic of China pharmaceutical administration law and the Lanzhou city, drug and medical device industry supervision regulations shall be punished:
(A) in violation of these regulations article Nineth, buying insecticide is not required when requests for information;
(B) violation of these measures article 12th, or prepared medicines outside the specified limits provided;
(C) in violation of these regulations article 16th, private pharmacies or medicine cabinet, or by post, forged prescriptions, counter open on-demand and free clinics, charity, counselling, probation, fairs and sold by others or disguised sales of drugs;
(D) violation of the first paragraph of this article 19th, had never obtained a pharmaceutical production license and certificate of GMP pharmaceutical production enterprises in the drug purchase medical oxygen.
33rd medical institution has any of the following circumstances, the municipal, County and State by the food and drug administration departments of the medical devices regulations and the supervision of disposable sterile medical devices regulations shall be punished:
(A) in violation of the provisions of this article 22nd, use without a registration certificate, a certificate, expired, invalid or obsolete medical equipment;
(B) violation of these measures article 23rd, no strict implementation of the medical devices regulations.
Article 34th medical institutions violating these rules article 27th, not strict management of narcotic drugs, psychotropic drugs, medical toxic drugs for medical use of radioactive drugs, precursor chemicals and vaccines, by the Health Division of responsibilities for the Executive Department and food and drug supervision departments dealt with according to law.
35th food and drug supervision departments and its inspection staff shall have any of the following circumstances, be administrative sanctions according to law constitutes a crime, criminal responsibility shall be investigated in accordance with law:
(A) receiving the report or medical institutions in medical device quality report shall be handled in a timely manner, resulting in negative consequences;
(B) received a medical device adverse events of emergent group report fails to activate contingency plans in a timely manner, resulting in negative consequences;
(C) issue a false inspection and test reports or an offence charged;
(D) participation in medical device marketing activities;
(E) other acts of abuse, malpractice, neglect their duties.
Article 36th on food and drug supervision departments and relevant departments in accordance with these measures of administrative punishment against, may apply for administrative reconsideration or bring an administrative suit.
37th, beauty, health, sanitation and epidemic prevention, family planning, disease prevention, diagnosis, treatment and care activities of the agencies and units in accordance with the measures implemented. 38th article of the rules take effect on May 1, 2011.