《广东省深圳经济特区实施〈医疗机构管理条例〉若干规定》实施细则（2002年修订）（1997年11月7日深圳市人民政府令第65号发布，2002年7月23日深圳市人民政府令第118号修订）

　　第一条 根据《深圳经济特区实施〈医疗机构管理条例〉若干规定》（以下简称《规定》）第五十一条的规定，制定本实施细则。

　　第二条 市卫生行政管理部门根据每一万人口（包括暂住人口）设立一个医疗机构的原则对医疗机构实施总量控制，各区结合本区的人口分布、医疗资源、医疗需要和现有医疗机构的分布等实际情况，制定本区的医疗机构设置规划，报市卫生行政管理部门核定。

　　市卫生行政管理部门在各区制定的规划基础上，根据统筹规划的原则，制定全市的医疗机构设置规划。

　　第三条 区卫生行政管理部门在市卫生行政管理部门公布的受理期间统一受理医疗机构的开办申请。

　　申请开办医疗机构的单位或个人，应向拟申请开办医疗机构所在地的区卫生行政管理部门提交筹建申请。

　　第四条 公民申请开办个体或合伙诊所的，应具备下列条件：

　　（一）具有医师以上专业技术资格并取得《执业资格证书》；

　　（二）身体健康且能亲自主持医疗工作；

　　（三）至申请日止，二年内未发生二级以上医疗事故。

　　第五条 申请开办门诊部、诊所的单位或个人应向卫生行政管理部门提交下列材料：

　　（一）拟设医疗机构的名称、地址；

　　（二）开设的科目、医疗设备、专业卫生人员状况；

　　（三）拟设医疗机构的建筑面积；

　　（四）污水、污物的处理方案。

　　第六条 申请开办医院的单位或个人，向卫生行政管理部门提交的《可行性分析报告》应包括以下内容：?

　　（一）拟设医疗机构的名称、地址；?

　　（二）拟设医疗机构服务方式、服务时间和诊疗科目；

　　（三）拟设医疗机构建筑面积、医院床位编制；

　　（四）拟设医疗机构的组织结构、专业卫生人员状况；

　　（五）拟设医疗机构的仪器、设备配备；

　　（六）污水、污物的处理方案。

　　第七条 区卫生行政管理部门应将开办医疗机构的申请及其他应提供的材料提交医疗机构专家评议委员会评议。

　　医疗机构专家评议委员会评议时，参加评议的委员的人数必须超过专家评议委员会总人数的二分之一；申请须经三分之二以上到会委员评议通过，方为合格。

　　第八条 对经医疗机构专家评议委员会评议合格的申请者，区卫生行政管理部门根据医疗机构设置规划审核后，做出批准或不批准的决定。

　　对予以批准的申请者，由所在区卫生行政管理部门核发《医疗机构筹建批准书》；对不予批准的，应以书面形式说明理由并通知申请者。

　　第九条 《医疗机构筹建批准书》从核发之日起，有效期为：

　　（一）三级医院为五年；

　　（二）二级医院为三年；

　　（三）一级医院为一年；

　　（四）门诊部为一年；

　　（五）诊所为半年。

　　申请筹建医院的，在《医疗机构筹建批准书》有效期内不能完成筹建工作的，可在有效期届满前三十日内，向区卫生行政管理部门申请延期，经核准后，可延期半年至一年。

　　未取得《医疗机构筹建批准书》或持失效的《医疗机构筹建批准书》，不得从事医疗机构的筹建活动。?

　　第十条 取得《医疗机构筹建批准书》的单位或个人，其筹建工作完成后，应向区卫生行政管理部门申请执业登记。申请医疗机构执业登记时，申请者应按《规定》第十条提交相关证明材料。

　　第十一条 区卫生行政管理部门在受理医疗机构执业登记申请后三十日内，应按《规定》进行审查和实地核实。对符合执业条件的申请者，发给《医疗机构执业许可证》；对不符合执业条件的申请者，应限期改正。

　　第十二条 医疗机构变更名称、地址、主要负责人、诊疗科目、床位、注册资金等，应向区卫生行政管理部门提出申请，并提交下列材料：

　　（一）《医疗机构变更登记申请书》；

　　（二）申请变更登记的原因和理由；

　　（三）卫生行政管理部门规定应提交的其他材料。

　　区卫生行政管理部门应在受理申请之日起三十日内做出是否批准变更的决定。但对变更主要负责人、诊疗科目、床位的，区卫生行政管理部门须先提交医疗机构专家评议委员会评议，并根据医疗机构专家评议委员会的评议结果和医疗机构设置规划做出是否批准变更的决定。

　　第十三条 卫生行政管理部门对医疗机构实行校验制度：

　　（一）医院自《医疗机构执业许可证》核发之日起每三年校验一次；

　　（二）门诊部和诊所自《医疗机构执业许可证》核发之日起每一年校验一次。

　　第十四条 医疗机构应在校验期满前一个月，向区卫生行政管理部门提出校验申请，并提交下列材料：

　　（一）医疗机构校验申请书；

　　（二）《医疗机构执业许可证》副本；

　　（三）负责人名单和卫生技术人员名单等有关材料。

　　区卫生行政管理部门应在受理校验申请之日起三十日内完成校验。

　　第十五条 区卫生行政管理部门应将本区医疗机构的开办、变更、注销和校验情况定期向社会公布。

　　第十六条 医疗机构一般只能使用一个名称。名称的使用应符合以下原则：

　　（一）名称由识别名和专有名组成。专有名应与医疗机构规模、诊疗科目相适应；

　　（二）企事业单位、社会团体开办的医疗机构应以设置单位名称作为识别名；个人和合伙开办的医疗机构应以个人姓名或姓作为识别名；

　　任何医疗机构不得以行政区划名称作为医疗机构识别名称。

　　第十七条 不同申请者申请使用相同名称时，由申请在先的单位或个人使用该名称。

　　第十八条 个人和合伙诊所不得聘用卫生技术人员从事医疗专业工作。

　　其他医疗机构聘用卫生技术人员从事医务工作时，应在聘用之日起七日内到其所在地的区卫生行政管理部门备案，并应提供下列材料：

　　（一）用人单位的《医疗机构执业许可证》；

　　（二）被聘用人员的身份证和《执业资格证书》原件及复印件；

　　（三）被聘用人员的离退休证明、待业证明或辞职证明等有关证明材料；

　　（四）医疗机构与被聘用人签订的聘用合同。

　　第十九条 医疗机构必须按照许可的科目执业，不得超范围开设科目，从事诊疗活动。

　　第二十条 医疗机构不得截留鼠疫、霍乱、结核等国家禁止截留的传染病病人。

　　第二十一条 医疗机构应按规定设置药房，并凭处方笺发药，不得对外销售药品。

　　第二十二条 未领取制剂许可证的医疗机构不得配制制剂；已取得制剂许可证的医疗机构，配制的制剂只能供本医疗机构治疗的患者使用，不得以任何方式销售配制的制剂。

　　第二十三条 医疗机构不得使用未经检定或检定不合格的计量器具。

　　第二十四条 医疗广告必须遵守国家和地方广告管理的有关规定。

　　第二十五条 医疗机构的标牌应按市卫生行政管理部门规定的标准制作。

　　第二十六条 医疗机构的卫生技术人员上岗时必须统一着装，并佩戴卫生行政管理部门统一印制的上岗证。

　　第二十七条 未取得或持失效的《医疗机构筹建批准书》从事医疗机构筹建活动的，由卫生行政管理部门责令其停止非法筹建活动，并处三千元罚款。

　　第二十八条 医疗机构超出《医疗机构执业许可证》核定的范围开设科目的，由卫生行政管理部门责令其撤销非法开设的科目，没收其非法开设科目所使用的药品、器械及非法所得，并处以五千元至二万元罚款；拒不改正的，吊销其《医疗机构执业许可证》。

　　第二十九条 医疗机构未经批准，擅自变更名称、注册资金或主要负责人的，由卫生行政管理部门处以三千元罚款。擅自变更地址的，由卫生行政管理部门责令其改正并处以一万元罚款；拒不改正的，吊销其《医疗机构执业许可证》。

　　第三十条 医疗机构违反规定不申请校验且继续从事诊疗活动的，由卫生行政管理部门责令其限期补办校验手续，并处以五千元罚款；拒不办理校验手续的，吊销其《医疗机构执业许可证》。

　　第三十一条 医疗机构的名称不符合规定要求的，由卫生行政管理部门责令其改正；拒不改正的，处以三千元罚款，并可由卫生行政管理部门强制改正。

　　第三十二条 医疗机构违反规定聘用人员从事医疗卫生技术工作的，由卫生行政管理部门责令其改正，并处以五千至一万元罚款；情节严重的，责令其停业整顿，或吊销其《医疗机构执业许可证》。

　　第三十三条 医疗机构截留鼠疫、霍乱、结核等国家禁止截留的传染病病人的，由卫生行政管理部门处以一万元罚款。

　　第三十四条 未使用市卫生行政管理部门统一印制的病历、诊疗手册、处方笺、证明书的，由卫生行政管理部门责令其改正，并处以一千元罚款。

　　第三十五条 医疗机构违反规定设置药房或不凭处方笺发药或对外销售药品的，由卫生行政管理部门责令其改正，并处以五千元罚款。

　　第三十六条 医疗机构违反规定设置标牌的，由卫生行政管理部门责令其改正；拒不改正的，处一千元罚款，并由卫生行政管理部门强制改正，改正费用由医疗机构承担。

　　第三十七条 医疗机构超过三个月不向卫生行政管理部门缴纳管理费的，每超一天加收5‰的滞纳金。

　　第三十八条 对医疗机构的同一违法行为，由先行检查发现的卫生行政管理部门处罚，市、区卫生行政管理部门不得重复处罚。

　　第三十九条 本实施细则自颁布之日起施行。

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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