Pharmaceutical And Medical Devices Industry In Lanzhou City Regulatory Approach

Original Language Title: 兰州市药品和医疗器械从业监督管理办法

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Pharmaceutical and medical devices industry in Lanzhou city regulatory approach (August 19, 2009 Lanzhou City Government 17th times Executive Conference considered through August 31, 2009 Lanzhou City Government makes [2009] 5th, announced since October 1, 2009 up purposes) first article to strengthening drug, and medical devices (following referred to machinery) of practitioners management, specification practitioners units, and personnel behavior, ensure public with medicinal armed security, according to People's Republic of China drug management method, and People's Republic of China drug management method implementation Ordinance and

    Supervision and administration of medical devices Ordinance and other provisions of laws and regulations, combined with the city's actual, these measures are formulated.

    Article within the administrative area of the city and controlled production, management, activities relating to the management and supervision of entities or individuals should comply with these measures.

    Otherwise provided by laws and regulations, from its provisions.

    Mentioned in the procedures and machinery production, distribution, use, activities relating to the management and supervision of entities or individuals, including:

    (A) medical device manufacturers and their employees;

    (B) controlled wholesale and retail enterprises and their workers;

    (C) machinery, such as the use of units of medical institutions and their employees;

    (D) the city, County and district food and drug supervision and Management Department (hereinafter referred to as the drug agency), supervision, inspection agencies and their staff.

    Article, machinery industry, municipal administration Department in charge of the supervision and management of the work.

    Industrial and commercial, taxation, health, price, quality and technical supervision, labor and social security, family planning, investment and other administrative departments shall, within their respective mandates, supervision and administration of machinery industry.

    Article fourth engaged in machinery production, operation and use of the units and individuals shall strictly comply with laws, regulations, rules and regulations and relevant industry standards.

    Engaged in machinery production, operation and use of the units and individuals, shall on its production, management and use of medical device quality.

    Engaged in machinery production, operation and use of the units and individuals shall follow the principles of fairness, integrity, honesty, discipline, civilization practice, shall be without prejudice to the legitimate rights and interests of consumers, must not harm the social and public interests.

    Article fifth medical device industry associations should play a role overseeing, coordinating and service, strengthening self-discipline, standardize trade, safeguard the interests of Association members and industry order; strengthening public health knowledge, advocacy, and lead consumers to choose legitimate producers and production, management and use of medical device products as well as legal identification of medical device products. Sixth to encourage citizens, legal persons and other organizations to the machinery industry conduct supervision.

    For acts in violation of these measures, all units and individuals have the right to report to the drug regulatory authority. Drug regulatory authority shall publish the report to the Department's e-mail address or phone reports of received shall be promptly and completely recorded and properly preserved and whistle-blowers confidentiality.

    Matters reported to the duties of this Department, shall accept, in accordance with the verification, processing, replies; not part of the duties of the Department, shall be referred to the right of the Department and inform the informers.

    Article seventh medical device production, management and use of quality management and inspection personnel shall have a pharmacy-related professional qualifications or titles with pharmacy, specialized training, drug administration departments, and certified after passing the examination.

    Eighth of medical device production, management and use drug testing units or bodies or persons, shall be subject to municipal drug administration operational guidance for drug inspection institutions set up. Nineth machinery production, operation and units engaged in inspection, maintenance, metering, storage, marketing and so on personnel should have appropriate qualifications or a certain degree of education, specialized training, drug administration departments, and certified after passing the examination.

    Access to employment regulations of the State post, staff should be made through the identification of vocational skills and professional credentials before they can post.

    Article tenth machinery production, operating machinery and users should be on their staff-related laws, regulations, and professional training, establish training records, training records should document the training time, place, content and training of personnel.

    Municipal drug administration departments are engaged in pharmaceuticals, medical devices and products marketing and personnel working in relevant laws, regulations and professional continuing education.

    Non-prescription drugs business of b class drug retailer, shall be equipped with the municipal drug administration examination by qualified service personnel.

    Violation of the provisions of this article, by city, County and district drug administration warning, rectification; fails to make corrections, shall be ordered to suspend production or business for rectification, and a fine of 2000 Yuan and 20,000 yuan fine.

    11th medical device production, operating and using units shall improve the management of machinery in China, and specifically provide for their staff.

    Medical device production, management and use of units and their employees shall not be any of the following acts:

    (A) deliberately mislead consumers purchased more than required for drugs, drug abuse;

    (B) intentionally exaggerated the efficacy of controlled, for-profit promotion machinery;

    (C) by tying, buy machinery, present medical device, buy merchandise donated machinery, to the public prescription drug or non-prescription drugs, medical devices;

    (D) sell by mail, Internet trading, including direct sales to the public prescription drug;

    (V) does not sell prescription drug prescription;

    (Vi) sales to individuals at high risk of implanting medical devices;

    (VII) for employees in the unit within this company engaged in machinery or facilitate illegal activities.

    Violation of the provisions of this article, by city, County and district drug regulatory authority to medical device production, management and use of units in a warning and order them to correct, and a fine of 3000 Yuan and 30,000 yuan fine.

    12th medical device production, wholesaling unit sent sales when machinery, shall provide the following information:

    (A) with supply unit the original seal, copies of business licenses and business licenses;

    (B) with supply unit the original seal of good manufacturing practices, pharmaceutical quality control standard of certification certificate;

    (C) the sealed by the supply units the original sales controlled copies of approval documents;

    (D) the sealed by the supply unit original copies of authorization;

    (E) the legal purchase and sale bills.

    Sales of imported machinery shall be provided in accordance with relevant regulations of the State or asking for documentation.

    Medical device production, wholesale unit sales personnel in this unit should be controlled sales of activities within the scope of authority, not part-time medical device sales activities in other units, not commissioned medical device sales activities shall not be approved by the drug authorities an address other than the place of storage or spot selling insecticide.

    Violation of the provisions of this article, by the city, County and district drug regulatory authority in accordance with the People's Republic of China of 73rd of the drug administration law shall be punished.

    Article 13th prescription drugs non-prescription drugs and medical device retail business during business hours shall be such that a licensed pharmacist or other legally recognized pharmaceutical technicians on the job, guiding customers reasonable buy medication use machinery and machinery advice.

    Violation of the provisions of this article, by city, County and district drug administration warning shall be ordered to correct; after the warning is still not corrected, fined 500 Yuan more than 1000 Yuan fine.

    14th medical device production, management and use of units, such as warehouses, pharmacies, should be commensurate with the machinery used by the premises, equipment, storage facilities and a hygienic environment, equipped with the appropriate pharmaceutical technical personnel and establishment of medical device quality management agencies or quality managers, establish a machinery storage system.

    Violation of the provisions of this article, by city, County and district drug administrations a rectification, if the circumstances are serious, informed.

    15th medical device production, management and use of unit employees must undergo an annual medical examination; new work and temporary work must be carried out health checks, obtain health certificates before they can post.

    Violation of the provisions of this article, machinery production, management and use of employment personnel worked in units without a health certificate for machinery production, marketing and use, or illness shall not be engaged in the industry who are not complying with the provisions transferred, by city, County and district drug agency ordered corrective action and fined 2000 Yuan and 20,000 yuan fine.

    16th medical device advertisement and propaganda, promotion activities must be truthful, legal, and is subject to specifications approved by the legal department shall not contain false content.

    Medical device production, management and use in station, dock, theatres, squares, residential communities for promotion activities should be 5th in publicity, promotion activities, drug regulatory authorities and accept supervision and management in the region.

    Violation of the provisions of the first paragraph, by the administration of industry and commerce in accordance with the People's Republic of China advertising related provisions of the law will be punished.

    Violation of the provisions of the second paragraph, by city, County and district drug administration warning shall be ordered to correct; after the warning is still not corrected, fined 500 Yuan more than 5000 Yuan fine.

    Article 17th out of medical device production, management and users in the LAN set up offices, in relevant operations, registration procedures, should be submitted to the municipal drug administration departments for the record.

    Municipal drug administration shall regularly publish outside machinery production, management and use in LAN set up offices to facilitate consumer queries.

    18th the drug agency in accordance with the provisions of the relevant laws, rules and regulations, carry out supervision and administration of medical device products duties, has the following powers:

    (A) entering the place of business to conduct inspections;

    (B) read, copy, attachment, seizure-related contracts, notes, account books and other relevant materials;

    (C) the attachment, arrest does not meet the statutory requirements of machinery products and their packaging materials, illegal use of raw materials, auxiliary materials and additives, agricultural inputs and tools, equipment used for illegal production;

    (D) seizure of harm to people's health and life safety hazard place.

    Medical device production, management and use of units when the drug agency supervision and inspection, and shall cooperate, refuse and hide.
19th the drug agency should establish machinery production, management and use of the unit and related fields to the database, update the change data and to the public, for the query.

    Medical device production, management and use units to carry out business activities, can the drug agency website verified by way of doing business in China medical device information.

    20th of municipal drug administration departments should establish machinery industry integrity auditing system.

    Medical device production, management and use of units and their employees violate laws, regulations, rules and related provisions of the industry, there are bad business behaviors, drug administration departments can be announcement through the news media, and take into account bad credit file.

    21st of municipal machinery industry association, associations and other institutions should be strengthened on this, machinery production, operating and using the units and their employees job skills training, continuing education and information services, technical advice, training, and so on.

    22nd medical device production, management and use of units and their employees violate laws, regulations, rules and regulations, and be dealt with according to law by the drug agency involving civil liability shall bear liability constitutes a crime, criminal responsibility shall be investigated according to law.

    Article 23rd machinery production, management and use units in China and its administrative penalties to the drug regulatory authority is dissatisfied, may apply for administrative reconsideration or bring an administrative suit.

    24th drug administrations and their staff in the supervision and administration of machinery industry, abuse, deception, negligence, by the competent authorities or competent supervisory organ directly responsible for personnel and other persons directly responsible shall be given administrative sanctions.

    25th article this way on specific applications, the municipal drug administration is responsible for the interpretation. 26th article of the rules take effect on October 1, 2009.