《深圳经济特区实施〈医疗机构管理条例〉若干规定》实施细则（修订） Detailed Rules on the Implementation of the Provisions of Shenzhen

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

　　Detailed Rules on the Implementation of the Provisions of Shenzhen Special Economic Zone on the Implementation of　the Administrative Regulations on Medical Institution

　　（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）

　　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）。

　　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.

　　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：

　　（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 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；

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

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

age.

　　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 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：

　　（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.

　　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.

　　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.

　　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， 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 adminis

trative 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 de

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