颁布日期：20020723 　实施日期：20020723 　颁布单位：深圳市人民政府

　　Detailed¹ Rules on the Implementation² of the Provisions of Shenzhen Special Economic Zone on the Implementation of　the Administrative³ Regulations on Medical Institution

　　（Promulgated⁴ 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）

　　Article 1 These detailed rules are formulated⁵ 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）。

　　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 appraisal⁶ and decision.

　　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 initiating⁷ 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 partnership⁸ clinic shall satisfy the following requirements：

　　（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；

　　（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：

　　（1） The name and address of the medical institution planned to be set up；

　　（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；

　　（4） The scheme for the treatment of polluted matters and sewage.

　　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：

　　（1） The name and address of the medical institution planned to be set up；

　　（2） The service mode， service time and diagnosis⁹ 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；

　　（5） The instruments and equipments of the medical institution to be set up；

　　（6） The scheme for the treatment of polluted matters and sewage.

　　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.

　　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 appraised¹⁰ 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 applicant¹¹ 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：

　　（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 expiration¹² of the validity period. The validity period may be extended for half a year to one year， after the application is examined and approved.

　　Any one， who has not acquired the Approval Certificate of Establishing Medical Institution or holds an invalid¹³ Approval Certificate of Establishing Medical Institution， may not undertake the preparation for establishing medical institution.

　　Article 10 The unit or individual having acquired the Approval Certificate of Establishing Medical Institution shall apply for registration¹⁴ 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.

　　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 License¹⁵ 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， number of beds， or registered capital， it shall file an application to the district administrative department of health， and submit the following materials：

　　（1） Application for Registration of the Change of the Medical Institution；

　　（2） The cause and reason of applying for registration of change；

　　（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.

　　Article 13 The administrative department of health shall carry out examination and check to medical institutions：

　　（1） A hospital shall be examined and checked every three years from the date when the Practicing License of Medical Institution is granted；

　　（2） The outpatient department or clinic shall be examined and checked every year from the date when the Practicing License of Medical Institution is granted.

　　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：

　　（1） The medical institution‘s application for examination and check；

　　（2） The duplicate of the Practicing License of Medical Institution；

　　（3） The name lists of the persons in charge and the health technical persons.

　　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.

　　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：

　　（1） The name shall be consisted of the identification title and exclusive title. The exclusive title shall be adaptable¹⁶ 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 applicants¹⁷ 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.

　　If other medical institution employs health technical person to undertake the medical work， it shall report the employment to the district administrative department of health， where it locates， for record within 7 days from the employment， and submit the following materials：

　　（1） The Practicing License of Medical Institution of the employer；

　　（2） The identification card of the employee， the original and copy of the Qualification of Practice；

　　（3） The retirement¹⁸ 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.

　　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 withhold¹⁹ the infectious patient of plague， cholera²⁰， or tuberculosis²¹，or other infectious patient who is prohibited by the State to be withheld²².

　　Article21 The medical institution shall set up the drugstore according to relevant provisions， and distribute the medicine according to the paper of prescription²³， 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.

　　Article 23 The medical institution shall not use the measurement instrument that is not calibrated²⁴ or calibrated to be unqualified.

　　Article 24 The advertisement on medical care shall observe relevant provisions of the State and local administration on advertisement.

　　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， confiscate²⁵ 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 revoked²⁶ the Practicing License of Medical Institution.

　　Article 29 If a medical institution arbitrarily changes its name， registered capital 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 supplementary²⁷ 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 compulsorily²⁸ 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 violation²⁹ 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 rectification³⁰， or be revoked the Practicing License of Medical Institution.

　　Article 33 If a medical institution withholds³¹ 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.

　　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.

　　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 compulsory³² correction measures， and the expenses of the compulsory correction measures shall be borne by the medical institution.

　　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 overdue³³ fine of 5‰ 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.

　　Article 39 These detailed rules shall go into effect as of the date of promulgation³⁴.

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