Detailed Rules on
the Implementation of the Provisions of Shenzhen Special
Economic Zone on the Implementation of the
Administrative
Regulations on Medical Institution
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(Promulgated by
Decree No.65 of the Shenzhen Municipal People' s Government on
November 7, 1997, as revised and promulgated
by Decree No.118 of
the Shenzhen Municipal People' s Government on July 23, 2002 for
the first time, revised and promulgated
by Decree No.135 of the
Shenzhen Municipal People' s Government on August 26, 2004 for
the second time.) |
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Article 1
These detailed rules are formulated according to the provisions
of Article 51 of the provisions of Shenzhen Special Economic
Zone on the Implementation of the Administrative Regulations on
Medical Institution (hereinafter referred to as the Provisions).
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Article 2
The municipal administrative department of health shall carry
out the control of total quantity of medical institutions
according to the principle, that the medical institutions shall
be set up for every 10,000 population (including the
temporary
resident population). Every district shall draw the set-up plan
of medical institutions in this district,
combining with the
actual circumstances of the population distribution, medical
resources, medical needs, distribution
of the existing medical
institutions, and shall submit the set-up plan to the municipal
administrative department of
health for appraisal and decision.
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The municipal
administrative department of health shall draw the set-up plan
of medical institutions in the whole city,
basing on the plans
of all districts, and according to the principle of overall
planning. |
Article 3
The district administrative department of health shall uniformly
accept applications for initiating medical institutions
in the
accepting period published by the municipal administrative
department of health. |
The unit or
individual applying for initiating a medical institution shall
submit an application for preparing the establishment
of the
medical institution to the district administrative department of
health, where the medical institution to be established
will
locate. |
Article 4
The citizen applying for initiating an individual or partnership
clinic shall satisfy the following requirements:
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(1) Having obtained
the professional technical qualification of higher than the
physician, and having acquired the Qualification
Certificate of
Practice; |
(2) Being healthy,
and being able to preside over the medical work personally;
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(3) Having not
caused any medical accident worse than second rank in the last
2 years before the application
date. |
Article 5
The unit or
individual applying for initiating a outpatient department or
clinic shall submit materials containing the
following
information to the administrative department of health:
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(1) The name and
address of the medical institution planned to be set up;
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(2) The conditions
of the subjects to be established, medical equipments and
professional health workers; |
(3) The built-up
area for the medical institution planned to be set up;
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(4) The scheme for
the treatment of polluted matters and sewage.
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Article 6
the Feasibility Report submitted to the administrative
department of health by the unit or individual applying for
initiating a hospital shall include the following contents:
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(1) The name and
address of the medical institution planned to be set up;
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(2) The service
mode, service time and diagnosis subjects of the medical
institution to be set up; |
(3) The built-up
area for the medical institution to be set up, and the number of
beds of the hospital to be set up; |
(4) The
organizational structure and the conditions of the professional
health workers of the medical institution to be
set up;
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(5) The instruments
and equipments of the medical institution to be set up;
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(6) The scheme for
the treatment of polluted matters and sewage.
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Article 7
The district administrative department of health shall refer the
applications for initiating medical institutions and
other
materials that shall be provided, to the Expert Appraisal
Committee of Medical Institution for appraisal.
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When the Expert
Appraisal Committee of Medical Institution makes appraisal, the
number of the committee members participating
in the appraisal
shall exceed one half of the total number of the members of the
Expert Appraisal Committee. The application
shall not be up to
standard, until it passes the appraisal with consent of more
than two- thirds of the committee members
who are present at the
appraisal meeting. |
Article 8
The district
administrative department of health shall check the application
appraised to be up to standard by the Expert
Appraisal Committee
of Medical Institution according to the set-up plan of medical
institutions, and make a decision
on approving or not approving
the application. |
The district
administrative department of health, where the domicile of the
applicant locates, shall grant the Approval
Certificate of
Establishing Medical Institution to the applicant, whose
application is approved. The district administrative
department
of health shall give reason in writing to the unapproved
application, and inform the applicant. |
Article 9
The validity of the Approval Certificate of Establishing Medical
Institution shall last from the granting date:
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(1) Five years for
the hospital of the third grade; |
(2) Three years for
the hospital of the second grade; |
(3) One year for
the hospital of the first grade; |
(4) One year for
the outpatient department; or |
(5) Half a year for
the clinic. |
If the applicant
applying for preparing to establish a hospital, and can not
complete the preparation work within the
validity period of the
Approval Certificate of Establishing Medical Institution, he may
apply for extension to the district
administrative department of
health in 30 days before the expiration of the validity period.
The validity period may
be extended for half a year to one year,
after the application is examined and approved.
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Any one, who has
not acquired the Approval Certificate of Establishing Medical
Institution or holds an invalid Approval
Certificate of
Establishing Medical Institution, may not undertake the
preparation for establishing medical institution.
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Article 10
The unit or
individual having acquired the Approval Certificate of
Establishing Medical Institution shall apply for registration
of
practice to the district administrative department of health,
after the preparation work of establishment is completed.
The
applicant applying for the practice registration of the medical
institution shall submit relevant certification materials
according to the Article 10 of the Provisions.
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Article 11
The district
administrative department of health shall carry out the
examination and the on-the-spot check according to
the
Provisions within 30 days from the date when it accepts the
application for the practice registration of the medical
institution. The applicant shall be issued the Practicing
License of Medical Institution, if his application satisfies
the
requirements of practice. The applicant shall be ordered to make
correction within a time limit, if his application
does not
satisfy the requirements of practice. |
Article 12
If a medical
institution plans to change its name, address, person in charge,
diagnosis subject, or quantity of beds,
it shall file an
application to the district administrative department of health,
and submit the following materials:
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(1) Application for
Registration of the Change of the Medical Institution;
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(2) The cause and
reason of applying for registration of change;
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(3) Other materials
that shall be submitted according to the requirement of the
administrative department of health. |
The district
administrative department of health shall make the decision on
whether to approve the change or not within
30 days from the
date when it accepts the application. But if the change involves
the person in charge, diagnosis subject
or number of beds, the
district administrative department of health shall refer it to
the Expert Appraisal Committee
of Medical Institution for
appraisal, and make the decision on whether to approve the
change or not according to the
appraisal conclusion of the
Expert Appraisal Committee of Medical Institution and the set-up
plan of the medical institutions.
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Article 13
The
administrative department of health shall carry out examinations
and checks to medical institutions according to relevant
provisions of the State: |
Article 14
The medical
institution shall file the application for a new examination and
check to the district administrative department
of health one
month before the expiration of the period of examination and
check, and submit the following materials:
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(1) The medical
institution' s application for examination and check;
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(2) The duplicate
of the Practicing License of Medical Institution;
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(3) The name lists
of the persons in charge and the health technical persons.
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The district
administrative department of health shall complete the
examination and check within 30 days from the date
when it
accepts the application for examination and check.
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Article 15
The district administrative department of health shall announce
the establishments, changes, cancellations, examinations
and
checks of medical institutions in this district to the public
periodically. |
Article 16
A medical institution may only use one name generally. The name
use shall accord with the following principles:
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(1) The name shall
be consisted of the identification title and exclusive title.
The exclusive title shall be adaptable
to the medical
institution' s scale and diagnosis subjects; |
(2) The medical
institution established by the enterprise, institution or mass
organization shall use the name of the
establishing unit as its
identification title; the medical institution established by the
individual or partners shall
use the individual full name or
surname as its identification title; No medical institution may
use the name of an administrative
division as the identification
title of medical institution. |
Article 17
If different
applicants apply for using the same name, the unit or individual
who firstly applies may use it. |
Article 18
The individual and partnership clinic shall not employ health
technical person to undertake the medical work.
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If other medical
institution employs a health technical person to undertake
medical work, it shall inform the employment
to the district
administrative department of health in writing, where it
locates, within 7 days from the employment,
and submit the
following materials: |
(1) The Practicing
License of Medical Institution of the employer;
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(2) The
identification card of the employee, the original and copy of
the Qualification of Practice; |
(3) The retirement
certification, unemployment certification or resignation
certification of the employee and other relevant
certification
materials; |
(4) The employment
contract concluded by the medical institution and the employee.
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Article 19
The medical institution shall practice according to the
permitted subjects, and shall not set up a subject beyond the
scope to undertake diagnosis activities. |
Article 20
The medical
institution shall not withhold the infectious patient of plague,
cholera, or tuberculosis,or other infectious
patient who is
prohibited by the State to be withheld. |
Article21
The medical institution shall set up the drugstore according to
relevant provisions, and distribute the medicine according
to
the paper of prescription, and shall not sell the medicine to
the outside. |
Article 22
The medical institution without the preparation permit shall not
compound medicines. The medical institution with the
preparation
permit may only provide the medicines compounded by it to the
patients, who are treated by this medical institution,
and shall
not sell the compounded medicines by any means.
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Article 23
The medical institution shall not use the measurement instrument
that is not calibrated or calibrated to be unqualified.
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Article 24
The advertisement on medical care shall observe relevant
provisions of the State and local administration on
advertisement.
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Article 25
The name board of medical institution shall be made according to
the standard provided by the municipal administrative
department
of health. |
Article 26
The health
worker or health technical person of medical institution in the
work shall wear uniform dress and the duty
card uniformly made
by the administrative department of health. |
Article 27
Any one, who undertakes the activity of preparing the
establishment of a medical institution without the Approval
Certificate of Establishing Medical Institution or with an
invalid Approval Certificate of Establishing Medical
Institution,
shall be ordered to stop the illegal preparation
activity, and be imposed a fine of 3,000 yuan by the
administrative
department of health. |
Article 28
If a medical institution set up a subject beyond the scope
approved in the Practicing License of Medical Institution,
the
administrative department of health shall order it to cancel the
subject illegally set up, confiscate the medicines
and
instruments using for the subject illegally set up, and the
illegal gains, and impose a fine of 5,000 to 20,000 yuan.
If the
medical institution refuses to make correction, it shall be
revoked the Practicing License of Medical Institution.
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Article 29
If a medical institution arbitrarily changes its name, or person
in charge without being approved, it shall be imposed
of a fine
of 3,000 yuan by the administrative department of health. If it
arbitrarily changes its address, it shall be
ordered to make
correction and imposed a fine of 10,000 yuan by the
administrative department of health. If it refuses
to make
correction, it shall be revoked the Practicing License of
Medical Institution. |
Article 30
If a medical institution does not apply for examination and
check according to relevant provisions, and continues to
undertake the diagnosis activities, it shall be ordered to apply
for supplementary examination and check within a time
limit, and
be imposed a fine of 5,000 yuan by the administrative department
of health. If it refuses to apply for supplementary
examination
and check within the time limit, it shall be revoked the
Practicing License of Medical Institution. |
Article 31
If the name of a medical institution doesn' t accord with the
requirements of relevant provisions, the administrative
department of health shall order it to make correction. If it
refuses to make correction, it shall be imposed a fine
of 3,000
yuan, and be compulsorily corrected by the administrative
department of health. |
Article 32
If a medical institution employs person to undertake the medical
or technical work of health in violation of relevant
provisions,
it shall be ordered to make correction, and be imposed a fine of
5,000 to 10,000 yuan by the administrative
department of health.
If the circumstances are serious, it shall be ordered to stop
business for internal rectification,
or be revoked the
Practicing License of Medical Institution. |
Article 33
If a medical institution withholds the infectious patient of
plague, cholera, tuberculosis, or other infectious patient
who
is prohibited by the State to be withheld, it shall be imposed a
fine of 10,000 yuan by the administrative department
of health.
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Article 34
If a medical institution doesn' t use the medical record book,
medical handbook, prescription paper or certification
uniformly
printed by the municipal administrative department of health, it
shall be ordered to make correction, and be
imposed a fine of
1,000 yuan by the administrative department of health.
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Article 35
If a medical institution installs drugstore, or distributes
medicine without prescription paper, or sells medicine to
the
outside, in violation of relevant provisions, it shall be
ordered to make correction, and be imposed a fine of 5,000
yuan
by the administrative department of health. |
Article 36
If a medical institution installs its name board in violation of
relevant provisions, it shall be ordered to make correction
by
the administrative department of health. If it refuses to make
correction, it shall be imposed a fine of 1,000 yuan.
The
administrative department of health may take compulsory
correction measures, and the expenses of the compulsory
correction measures shall be borne by the medical institution.
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Article 37
If a medical institution fails to pay the administrative fee to
the administrative department of health exceeding 3 months,
it
shall pay a extra overdue fine of 5бы of the fee for every
exceeding day. |
Article 38
The medical institution committing illegal act shall be punished
by the administrative department of health, which firstly
finds
out the illegal act in the examination. The municipal and
district administrative departments of health shall not
make
punishments to the same illegal act repeatedly.
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Article 39
These detailed rules shall go into effect as of the date of
promulgation. |