Qiqihar Medical Access Approach

Original Language Title: 齐齐哈尔市医疗市场准入办法

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(June 23, 2005, Qiqihar city, Government 23rd times Executive Conference considered through June 23, 2005, Qiqihar city, Government makes 3rd, announced since July 23, 2005 up purposes) first chapter General first article for strengthening on medical market supervision management, guarantee medical security, according to People's Republic of China practice industry physician method and State medical institutions Management Ordinance, and medical institutions Management Ordinance implementation rules, and Heilongjiang province medical institutions management approach, about legal, and
    Rules and regulations, combined with the city's actual, these measures are formulated.
    Article within the administrative area of the city of epidemic prevention, the frontier health and quarantine, medical research and teaching, medicine, treatment, family planning, clinical examination, blood collection and supply agencies in the diagnosis and treatment undertaken outside the scope of the Agency's business activities, as well as medical services such as massages, beauty massages, cosmetic services and procedures apply.
    Article city and County (City), the Administrative Department of health responsible for regional medical institutions according to law (including branch offices) and its practitioners, medical subjects, technology, medical device market access work.
    Chapter II access to medical institutions, medical institutions, article in accordance with the installation plan, sets basic standards of medical institutions, access to city and County (City), the establishment of medical institutions issued by the health Administrative Department of ratification or the establishment of a medical institution for the record of receipts and medical institutions deal with registration formalities before they can practice. Fifth article set medical institutions, should by following management permission approval: (a) not set bed of medical institutions and level medical institutions, Jianhua district, and longsha district, and tiefeng district, and fulaerji, and Angangxi District, and melies district, and nianzishan district (following referred to seven District) within of, by district health administration sector review agreed Hou, reported city health administration sector approval, to set medical institutions approved book; County (City) range within of, by County (City) health administration sector approval agreed Hou,
    Reported to the municipal public health Administrative Department, and by the municipal public health Administrative Department of the establishment of a medical institution for the record receipts.
    (B) level II medical agencies and city and County Hospital for specialist (standing), 99-bed rehabilitation hospital, 299-bed nursing home, first aid stations, and community service centers (stations) and other medical institutions, approval by the municipal public health Administrative Department, issued after the approval of the establishment of a medical institution, to the provincial health administration departments for the record.
    (C) the third level medical institutions, rehabilitation hospital of 100 beds or more, more than 300-bed nursing home, first-aid centers and medical institutions directly under the provincial health Administrative Department, approved by the provincial health Administrative Department, issued a letter of approval of the establishment of a medical institution.
    Sixth application for establishment of a medical institution shall be under the management of medical institution under the State Council Ordinance and its implementing rules and other rules, and submit related materials.
    Article seventh city, County (City), the administrative departments for public health shall from the date of accepting an application for setting in the 30th, to approve or not to approve a written reply; approve and issue a letter of approval of the establishment of a medical institution. Article eighth medical institutions approved by the applicant should be the establishment of a medical institution within the validity period of the time limit to declare practising registration.
    Term of validity of the approval of the establishment of a medical institution, the three-level medical institutions for 3 years, secondary medical institutions for 2 years medical and medical institutions not located bed for 1 year.
    Nineth application for practising registration shall be under the management of medical institution under the State Council Ordinance and its implementing rules and other rules, and submit related materials.
    Tenth of municipal or County (City), the administrative departments for public health shall accept the practice of medical institutions within 45 days from the date of application for registration, in accordance with administrative privileges to complete the audit work, and meet the requirements, issue a practising certificate for medical institution, and announced to the public; does not meet the criteria, the audit results and the reasons for it in writing notify the applicant.
    Article 11th running of medical institutions as well as in the medical business enterprises of all types, who obtained a medical license to practice shall register to register with the Administrative Department for industry and commerce, after registration, may engage in business activities.
    12th State organs, enterprises and institutions in accordance with the basic standards set for employees of national medical services clinic, clinic, Health Center (room), the Administrative Department of health under the county level report, made the establishment of a medical institution for the record of receipts and the local people's Governments at the county level administrative Department for health practice registration, having obtained a medical license to practice, before they can practice.
    Serve the employees of medical institutions without permission and change registration shall not be open to the public. 13th medical organizations changed name, domicile, legal representative, ownership, service, services, registered capital (capital), medical subjects, beds (the Chair) shall be made to the original registration organ for change registration practice.
    The practising certificate for medical institution shall not transfer, lend.
    These changes need to go through the set up approval procedures, apply for alteration registration, should go through the settings and approval procedures.
    Dynamic management of courses in medical institutions, medical institutions set basic standards and fulfil new accounts shall comply with the access and approval procedures.
    14th Administrative Department of public health has approved the practice of implementation of the checking system of medical institutions.
    City-level medical institutions approved by the health Administrative Department practice of verification for a period of 3 years; the County (City), the Administrative Department of Health approved the practice of medical institutions in the calibration period is 1 year.
    15th medical institutions shall in the check expire 3 months before applying to the original practice of the Administrative Department of health check, administrative departments for public health shall from the date of accepting an application for checking complete calibration work within the 30th and announced to the public.
    16th medical organizations out of business, must be registered with the registration authority, after approval by the registration authority, withdraw the practicing certificate for medical institution.
    Subject to alteration, expansion, relocation cause, medical authorities closed shall not exceed 1 year.
    17th chapter officers access in the City set up clinics, you must meet the following conditions: (a) the physician practicing technical examination made of the physicians practicing certificate, (ii) obtained the certificate or a practicing doctor physician after the title, 5 years clinical work in the same profession; (c) the local permanent residence.
    Sino-foreign joint venture and cooperative medical institutions applicant qualifications according to the relevant State provisions. 18th article has following case one of of, shall not application set medical institutions: (a) cannot independent bear civil responsibility of units; (ii) is served or not has completely civil capacity of personal; (three) medical institutions on-the-job, and for disease former or leave without pay of medical personnel; (four) occurred two level above medical accident not full 5 years of medical personnel; (five) for violation about legal, and regulations and regulations, has was revoked practice industry certificate of medical personnel; (six) was revoked medical institutions practice industry license
    Medical institutions of the legal representative or principal responsible person; (VII) in men over 70 years old and above, women at 65 years old and above and (VIII) other circumstances that the State medical institutions cannot be set.
    Article 19th of health professionals physician practitioner Professional category examinations corresponding certificates, and certificate of the nurse practitioner or the certificate of licensed pharmacists, and after registration of the Administrative Department of health, can be registered in medical institutions in accordance with the place of practice, types of practice, practice practice.
    20th health Administrative Department for accepting applications to meet the conditions for registration, shall from the date of receipt of the application for registration in the 30th, uniformly printed and sent to the Ministry of health doctors practising certificates; do not meet the conditions refuse to register shall from the date of receipt of the application within the 30th notify the applicant in writing and state the reasons.
    21st outside health professionals to the city, should apply for practitioners (or nurse practitioner) registration or change of registration, within the time specified in the designated medical institutions, practice.
    Article 22nd of outside medical experts, medical institutions, should I invite short lectures, technical guidance or free clinic, hosting the diagnosis and treatment of medical institutions shall be located within the 3rd County (City), the Administrative Department of health registration and provide medical experts sent comments and invited medical experts, practising certificates of qualification. Fourth chapter medical technology admittance article 23rd outside the conventional techniques of diagnosis and treatment in medical institutions to implement special treatment or using high-tech diagnosis and treatment techniques of diagnosis and treatment, shall be reported to the municipal public health Administrative Department, commissioned by the municipal public health Administrative Department in accordance with the relevant provisions of expert assessment.
    Qualified through assessment, issued by the municipal public health Administrative Department of medical technology admittance proof not eligible, inform the applicant in writing.
    24th article medical technology application access approval content: (a) in international, and domestic first of technology project; (ii) International, and domestic has success carried out and local this units first application of technology project; (three) test sex of technology project; (four) thing shut personal health and security of major technology project (as liver, and kidney, and corneal, organ transplant); (five) other national Ministry of health and province health Office provides approval of technology project. The fifth chapter access 25th of large medical equipment medical equipment configuration, use document management and post personnel. Among them, the large medical equipment certificate shall be formulated by the health administrative departments and provincial health administration departments for approval to issue. Large medical equipment must meet the meter (agent) is accurate, safety, qualified before the use of performance indicators.
    Induction of large medical equipment personnel (including doctors, operators, engineering technicians, and so on) should be subject to job training, obtain the appropriate job qualifications.
    Article 26th acquisition of large medical equipment in public medical institutions, formalities according to relevant regulations of the State approval or for the record. Sixth chapter 27th penalties in violation of these rules, any of the following circumstances, by the city and County (City), the Administrative Department of health under administrative privileges shall be punished:

    (A) violation this approach fourth article, and 19th article provides, without approved unauthorized opened medical institutions practice or non-physician practice of, by County above government health administration sector ordered its stop practice industry activities, confiscated its illicitly acquired, and sentenced 100000 Yuan following of fine; on physician revoked its practice industry certificate; to patients caused damage of, law bear compensation responsibility; constitute crime of, law held criminal.
    (B) violation of these measures article 12th, medical institutions serving staff, unauthorized opening, by the administrative departments for public health shall be ordered to correct serious cases, revocation of license to practice medical organizations.
    (C) in violation of this article 13th paragraph, is not in accordance with the provisions for registration of change or transfer, lend the practising certificate for medical institution to non-health professionals, the people's Governments above the county level health administration departments confiscating, up to 3000 more than 5000 Yuan fines and revocation of license to practice medical organizations.
    (D) violation of this three paragraph article 13th, apart from emergency and first-aid, and activities beyond the scope of registration in medical institutions, in accordance with the implementing rules of regulation of medical institution 80th and the management of medical organizations in Heilongjiang province article 50th penalty.
    (E) violation of these measures article 14th, fails to check the practising certificate for medical institution, confiscation by the people's Governments above the county level health Administrative Department, and according to circumstances, impose fines below 3000 are serious, of the revocation of his medical license to practice.
    (Six) violation this approach 19th article provides, hired non-health technicians or medical institutions using health technicians beyond practice industry registered range of, by County above government health administration sector ordered its corrected, and sentenced 300 yuan above 3000 Yuan following of fine; for hired two name above without registered of practice industry personnel engaged in clinic activities of, sentenced 3000 Yuan above 5000 Yuan following of fine, plot serious of, revoked medical institutions practice industry license.
    (VII) in violation of the provisions of this article 22nd, medical institutions and health professionals by unauthorized, unauthorized free clinic activities carried out, the people's Governments above the county level health administrative departments shall be ordered to correct, and fined 1000 Yuan.
    (VIII) violation of these measures article 23rd, without filing or approval of diagnosis and treatment of high-tech project activities carried out without authorization, and ordered to go through formalities by the municipal public health Administrative Department; causing serious consequences, by the municipal public health Administrative Department shall be ordered closed for 6-12 months in serious cases, revoke a practising certificate program.
    (I) in violation of these regulations article 26th without the purchase of medical equipment license, unauthorized acquisition of large medical equipment, subject to seizure by the municipal public health Administrative Department, ordered to go through the formalities.
    Article 28th of fines pursuant to this Regulation shall be according to the relevant provisions for separating penalty paid executive; fines turned over to the financial sector.
    29th the health Administrative Department functionary, abuse of power by the supervisory departments administrative sanctions constitutes a crime, criminal responsibility shall be investigated according to law.
    30th article violates these rules, unlawful acts are outfitted with medicines, medical devices, and so on, by the food and drug supervision and administration in accordance with the relevant provisions.
    Seventh chapter supplementary articles article 31st this approach by the municipal people's Government is responsible for the interpretation.
                                                                                                                            32nd article this way since July 23, 2005.