Laws of the Guangdong Province

Several Rules of the Shenzhen Special Economic Zone on the Implementation of Regulations on the Administration of Medical Institutions

(Adopted on April 49, 1994 at the Twenty-Second Meeting of the Standing Committee of the First Shenzhen Municipal People' s Congress, revised for the first time according to Decision on Revising < Several Rules of the Shenzhen Special Economic Zone on the Implementation of Regulations on the Administration of Medical Institutions> of the Ninth Meeting of the Standing Committee of the Second Shenzhen Municipal People' s Congress of July 10, 1996, revised for the second time according to Decision on Revising < Several Rules of the Shenzhen Special Economic Zone on the Implementation of Regulations on the Administration of Medical Institutions> of the Fifteenth Meeting of the Standing Committee of the Third Shenzhen Municipal People' s Congress of April 26, 2002)

Chapter I General Provisions

       Article 1 In order to strengthen the administration of the medical institutions of the Shenzhen Special Economic Zone (hereinafter referred to as the Special Zone), standardize the practice requirements and the medical activities of medical institutions, and promote the sound development of medical and health work, these rules are hereby formulated in accordance with the basic principles of Regulations on the Administration of Medical Institutions of the State Council and the related law and regulations, and in the light of the practical conditions of the Special Zone.

       Article 2 The medical institutions referred to in these rules shall be those institutions such as clinics, outpatient departments, hospitals, etc., which are singularly or jointly run by enterprise and institution units, social organizations, armed forces, or individuals with self-raised funds, in the Special Zone, and open to the society.

       Article 3 The medical institutions shall abide by the law, regulations of the state, follow the goals of healing the wounded and rescuing the dying, preventing and curing diseases, and serving citizens for their health, comply with the regulations on medical and health work, and the rules on technical operations, adhere to the ethics of medical profession, insist on medical practice in a civilized way, and guarantee the quality of medical treatment.

       Article 4 The administrative department of health of the Shenzhen Municipal People' s Government shall be the department in charge of the medical institutions of the Shenzhen City. The administrative departments of health of the municipal, district people' s governments shall be responsible for the administration and supervision of the medical institutions within their own jurisdictions according to the related administrative regulations and these rules.

       The municipal administrative department of health shall establish an expert committee of evaluation of medical institutions which is responsible for evaluating the qualifications of medical institutions.

       The related departments of the municipal, district people' s government shall assist the responsible departments in the administration of medical institutions according to their respective duties.

       Article 5 The municipal, district administrative departments of health shall work out the municipal, district plans of the establishment and distribution of medical institutions according to the regional development plan of health and the principles of reasonable distribution, integrated structure, comprehensive function, and convenient service.

       The municipal, district plans of the establishment and distribution of medical institutions shall be made public at regular intervals.

Chapter II Examination and Approval, and Registration of Practice

       Article 6 The units and individuals opening medical institutions shall apply in advance to a district administrative department of health for setting up these institutions, go through the formalities of practice registration, obtain License of Medical Institution for Practice, and then be allowed to engage in the activities of diagnosis and treatment.

       Article 7 The units and individuals preparing to set up medical institutions shall apply to an administrative department of health in advance, and submit the following materials:

(1)   an application;

(2)   a report of feasibility analysis;

(3)   a selected location, a plan of building, and a plan of the layout of departments and sections.

Article 8 The district administrative departments of health shall unitarily accept

applications for setting up of medical institutions within the time limit of acceptance announced by the municipal administrative department of health, and hand over the applications to the expert committee of evaluation of medical institutions to evaluate their technology levels, practice conditions, etc. The district administrative departments of health shall make decisions of approval or rejection based on the evaluation result and the plan of the establishment and distribution of medical institutions announced by the municipal administrative department of health. If an application is approved, Approval of Preparation for Establishing a Medical Institution shall be issued to the applicant by the administrative department of health of the district which the applicant is affiliated with; if an application is rejected, an explanation shall be made in writing and sent to the applicant.

       Article 9 The units or individuals who have obtained Approval of Preparation of Establishment of a Medical Institution may apply to the district administrative departments of health for practice registration after their preparation of establishing of medical institutions are completed.

       Without Approval of Preparation of Establishment of a Medical Institution, an application shall not be accepted.

       Article 10 To apply for the registration of a medical institution for practice, the following requirements shall be satisfied and the following certificatory materials shall be submitted to the district administrative departments of health:

(1)   to meet the basic standards for a medical institution and to submit Approval of Preparation of Establishment of a Medical Institution and the certificatory materials concerning the person in charge;

(2)   to have a proper name, an organizational setup, and a place, and to submit the certificate of the ownership of business premises or legal lease contract;

(3)   to have the funds, facilities, equipments, and professional medical technological personnel corresponding with the practice, and to submit the capital audit report, the certificates of the quality and sources of the facilities and equipments, and the related certificates of the qualifications of medical technological personnel for practice;

(4)   to have appropriate regulations and rules;

(5)   to be able to be held independently for civil liability.

When various medical institutions are set up jointly by citizens, or by

corporations, or by a corporation and a citizen, the contract and the constitution

agreed on by the parties concerned after consultation shall be submitted.

       Article 11 The persons in charge of medical institutions shall have the qualifications for being a physician or for a higher rank, and they shall take charge of medical work themselves.

       Article 12 Within 30 days from the date of accepting an application for practice registration, an administrative department of health shall conduct the examination and verification. If an application has passed the examination and verification, License of Medical Institution for Practice shall be issued; if an application has failed to pass the examination and verification, the applicant shall be notified in writing.

       Article 13 The opening, modifying, canceling, screening of medical institutions shall be announced periodically by administrative departments of health.

       Article 14 The outpatient departments, hospitals engaging in birth control surgery, plastic surgery, and venereal disease treatment shall obtain Permit for Birth Control Surgery, Permit for Plastic Surgery, Permit for Venereal Disease Treatment respectively, and then be allowed to perform the respective operations.

       Clinics shall not engage in venereal disease treatment, birth control surgery, and plastic surgery.

       Permit for Plastic Surgery, Permit for Venereal Disease Treatment shall be issued and supervised by the municipal administrative department of health; Permit for Birth Control Surgery shall be issued and supervised by the municipal administrative department of health or the municipal administrative department of family planning, and the specific division of responsibilities shall be determined by the municipal government.

Chapter III Administration of Practice

       Article 15 Medical institutions shall hang the original copies of Permit of Medical Institution for Practice and Permit for Birth Control Surgery, Permit for Plastic Surgery, Permit for Venereal Disease Treatment corresponding with their specialty of treatment, the signs of their specialty, and the rates of treatment in the conspicuous spots of their practice places.

       Article 16 Any units and individuals shall not fabricate, alter, lease, loan, sell Approval of Preparation of Establishment of a Medical Institution, License of Medical Institution for Practice, Certificate of Qualifications for Practice, Permit for Birth Control Surgery, Permit for Plastic Surgery, and Permit for Venereal Disease Treatment.

       It shall be prohibited to contract out a medical institution and its departments and sections.

       Article 17 It shall be prohibited for a medical institution to post, print, and broadcast the advertisements on the results of medical treatments; it shall be prohibited for a medical institution to post, print, and broadcast the advertisements on the venereal disease treatment and the induced abortion surgery.

       Article 18 Medical institutions shall establish and perfect the technical files of medical practice, appropriately preserve medical records, prescriptions, complete hospitalization log-books, diagnosis conclusions, treatment bills, and diagnosis statements. The stubs of certificates of birth, death shall be kept for ever, and the other documents shall be preserved at least for 3 years.

       Medical institutions shall use the medical records, medical notebooks, prescription pads, report papers, certificate forms unitarily printed by the municipal administrative department of health, and also the invoices unitarily printed by the municipal office of local taxes.

       Article 19 Medical institutions shall not employ the following persons to engage in the technological work of medicine and health in the institutions:

(1)   the persons without Certificate of Qualifications for Practice;

(2)   the persons who have been disqualified for practicing medicine because of medical accidents, bad attitudes in medical practice, and moral wickedness;

(3)   the persons whose health are not suitable to medical practice.

Article 20 Medical institutions shall urge medical technological personnel to

abide by the medical ethics, heal the wounded and rescue the dying, take the responsibilities for patients' treatment, and prevent medical accidents.

      Article 21 Hospitals shall strictly implement the regulations on the admittance and discharge in hospitalization of patients, it shall be prohibited to use dishonest methods either in urging a patient to be hospitalized or in extending the hospitalization of a patient who should be discharged.

       Article 22 When collecting medical fees, medical institutions shall comply with the rates of medical charge set by the municipal administrative department of health jointly with the municipal administrative department of prices. Any medical institution shall not add any item of medical charge or raise the rates of medical charge without authorization.

       Article 23 When performing surgeries, special examinations, and special treatments for patients, medical institutions shall ask for the consent and signature of the patients or their relatives (or guardians, similarly hereinafter); in case there is no way to get the signature of a patient or his/her relatives, the physician in charge of treatment shall put forward a treatment plan and implement it after the head of the medical institution has agreed and signed the plan.

       Article 24 Medical institutions shall take prompt measures to treat and cure the persons who are seriously ill or the other patients who need emergency measures for treatment, and they may not shift the responsibility onto others and refuse to perform the treatment with any excuse, or take irresponsible attitude. If equipments or technical conditions are not good enough to provide treatment for a patient, the patient shall be referred to another medical institution immediately.

       Article 25 When providing special treatment and care for the patients suffering from infectious disease, mental disorder, and performing birth control surgery, plastic surgery, medical institutions shall abide by the related laws, regulations, and rules.

       It shall be strictly prohibited for a medical institution to identify the sex of a fetus in any way.

       Article 26 Medical institutions shall be responsible for the authenticity of diagnosis certificates or other professional documents they have issued. If damages have been done to others because of issuance of the various professional documents which are inconsistent with facts or misleading, or result in evading legal liabilities, the responsible persons and medical institutions shall be held liable for joint and several compensations.

       Article 27 Medical institutions shall not use the medicines which have no relationship with the subjects of their medical practice. As for the medicines under the state control such as mental disorder drugs, anesthetics, radioactive drugs, medical narcotics, etc., if they are indeed necessary for treatment, their use shall be allowed only after the municipal administrative department of health has approved it and the related formalities have been complied with.

       It shall be strictly prohibited for medical institutions to use fake medicines, bad medicines, ineffective medicines after expiration date, and medicines under prohibition.

       Without obtaining licenses for pharmaceutical production and distribution, medical institutions shall not produce, sell medicines.

       Article 28 Medical institutions shall take scientific, effective measures for sterilization, isolation, and disposal of sewage and waste, etc. in order to actively prevent and control the infection originating from medical practice and the spread of diseases.

       Article 29 When major disasters, accidents take place, medical institutions shall follow the arrangements of the administrative departments of health, participate in the efforts to provide disaster relief such as preventing and curing diseases, rescuing the wounded and ill persons.

       The medical institutions suffering an economic loss in providing disaster relief shall be appropriately compensated according to the related rules.

       Article 30 When medical accidents or other medical disputes take place, medical institutions shall promptly report to the administrative departments of health and take effective measures to seal up, preserve on-the-spot material objects and data, and shall not fabricate, alter, damage, destroy, hide evidence or evade the responsibilities in other way.

       Article 31 The medical technological personnel of medical institutions may join the Shenzhen Municipal Association of Medical Workers, accept its professional guide and supervision.

       Article 32 Medical institutions shall pay an administration fee to the administrative departments of health according to the rules.

Chapter IV Punitive Provisions

       Article 33 If a medical institution, in violation of Article 6 of these rules, has practiced medicine without obtaining License of Medical Institution for Practice, the administrative department of health shall ban it, confiscate medicines, appliances, and illegal earnings, and impose a fine of 5,000 to 20,000 RMB.

       Article 34 If a medical institution, in violation of Article 14 of these rules, has been engaged in the related medical practice without obtaining Permit for Birth Control Surgery, Permit for Plastic Surgery, or Permit for Venereal Disease Treatment, the administrative department of family planning, the administrative department of healthy shall order correction, confiscate illegal earnings, and impose a fine of 5,000 to 20,000 RMB; if the order of correction has been rejected or serious consequences have been caused, the administrative department of health shall revoke License of Medical Institution for Practice of this institution, and investigate into the legal liabilities of the principal responsible person and the related responsible persons according to law.

       Article 35 If a medical institution, in violation of Article 16 of these rules, has fabricated, altered, leased, loaned, sold the related approvals, licenses, qualification certificates, and contracted out its business, the administrative department of health shall confiscate its illegal earnings, revoke its related licenses and certificates, or disqualify the institution for medical practice, and impose a fine of 5,000 to 20,000 RMB.

       Article 36 If a medical institution, in violation of Article 17 of these rules, has posted, printed, broadcasted the advertisements for medical results and advertised venereal disease treatment and induced abortion surgery, the administrative department of health shall order it to stop business for rectification or revoke its Permit of Medical Institution for Practice.

       Article 37 If a medical institution, in violation of Article 19 of these rules, has employed unqualified persons to engage in technical work of medicine and health, the administrative department of health shall order correction, and impose a fine of 5,000 to 20,000 RMB; if the order of correction has been rejected, stopping business for rectification may be ordered, or License of Medical Institution may be revoked, even the criminal responsibility may be investigated into according to law, depending on the seriousness of circumstances.

       Article 38 If a medical institution, in violation of Article 21 of these rules, has used dishonest methods in urging a patient to be hospitalized or in extending the hospitalization of a patient who should be discharged, the resultant earnings shall be refunded to the patient and the administrative department of health may give criticism, warning, or impose a fine of one time to three times of the illegal earnings.

       Article 39 If a medical institution, in violation of Article 22 of these rules, has added any items of medical charge or raised any rates of medical charge without authorization, the administrative department shall handle the case jointly with the administrative department of prices according to the related rules.

       Article 40 If a medical institution and its personnel of medical practice have been irresponsible in the medical activities, caused an accident, and done damage to a patient, they shall be held liable for compensation to victims according to the related rules of the state. The administrative department of health shall give criticism, circulate a notice of criticism, disqualify them for practice, or revoke License of Medical Institution for Practice according to the seriousness of circumstances. If the circumstances are serious enough to have caused the disablement, death of a patient and led to the violation of the criminal law, the criminal responsibility shall be investigated into according to law.

       Article 41 If a medical institution, in violation of the second section of Article 25 of these rules, has been engaged in identifying the sex of a fetus, the administrative department of health or the administrative department of family planning shall order correction, , confiscate the illegal earnings and the related medicines, appliances, medical equipments, and impose a fine of 5,000 to 20,000 RMB; if the order of correction has been rejected, the administrative department of health shall revoke License of Medical Institution for Practice.

       Article 42 If a medical institution, in violation of Article 26 of these rules, has issued false documents, the administrative department of health shall order correction and impose a fine of 1,000 RMB; if any damage has been done, a fine of 1,000 to 5,000 RMB shall be imposed, or License of Medical Institution for Practice shall be revoked.

       Article 43 If a medical institution, in violation of Article 27 of these rules, has used fake medicines, bad medicines, ineffective medicines after the expiration date, and medicines under prohibition, or used the medicines under the state control without approval, or distributed medicines without license, the administrative department of health shall handle the case according to the state laws, regulations on the administration of medicines.

      Article 44 If a medical institution, in violation of Article 30 of these rules, has taken an action to evade the responsibility, the administrative department of health shall give criticism, warning, order stopping business for rectification, or revoke License of Medical Institution for Practice according to the seriousness of circumstances.

       Article 45 All the confiscated property and fines shall be handed over to the municipal department of finance.

       Article 46 If the administrative departments of health and their staff members have abused power, practiced favoritism and engaged in irregularities, asked for and accepted bribes in the medical administration, the units which they are affiliated with or the superior responsible departments shall punish them severely; if a crime has been constituted, the criminal responsibility shall be investigated into according to law.

       Article 47 If a party concerned has an objection to the specific administrative actions of the administrative departments of health or other related responsible administrative departments such as revoking or refusing to issue the related certificates of medical institutions, ordering to stop business for rectification or imposing fines, etc., an application for administrative review may be filed according to law or a legal action may be taken directly at the people' s court.

       In case of an objection to the specific administrative action of a district administrative department, an application for administrative review shall be filed to the municipal administrative department  within 15 days from the date of receiving an official reply or a notice of punishment decision; in case of an objection to the specific administrative action of the municipal administrative department, an application for administrative review shall be filed to the administrative review office of the municipal people' s government within 15 days from the date of receiving an official reply or a notice of punishment decision. If an applicant has an objection to the decision of administrative review, a legal action may be taken at the people' s court within 15 days from the date of receiving a notice of review decision.

       If a party concerned has failed both to execute a specific administrative punishment and to apply for administrative review or take a legal action, the related administrative department may apply to the people' s court for coercive enforcement.

Chapter V Supplementary Provisions

       Article 48 The state-run medical institutions referred to in these rules shall mean the medical institutions which are opened by the state investment and affiliated with the administrative departments of health.

       The clinics referred to in these rules shall mean the medical institutions which have clinical departments and sections as well as clinical physicians and attendants.

       The outpatient departments referred to in these rules shall mean the medical institutions which have clinical departments and sections, and related auxiliary clinical departments and sections, with the full capacity to function in diagnosis, treatment, and supply, and with patient beds for observation as well.

       The hospitals referred to in these rules shall mean the medical institutions which have more beds to hospitalize patients than the prescribed number and also the full capacity to function in diagnosis, treatment, prevention, health care, rehabilitation, and supply.

       The medical technical personnel referred to in these rules shall mean the medical professional personnel and the medical professional assistants, including the clinical medical personnel of the traditional Chinese medicine and the Western medicine, and the clinical assistants for health care, tests, radioactive work, midwifery, pharmacy, etc.

       Article 49 The administration of the medical institutions which are established within the Special Zone by the people from Hong Kong, Macao, Taiwan or foreigners shall be carried out by reference to these rules. If the laws, regulations of the state stipulate otherwise, they shall be honored.

       Article 50 The medical institutions which were approved for practice before these rules take effect shall go through the formalities of checkup according to these rules within 10 months from the date when these rules take effect, and obtain once again corresponding licenses. In case of failure to go through the formalities by the deadline, it shall be handled according to Article 33 of these rules.

       Article 51 The Shenzhen Municipal People' s Government may formulate detailed implementation measures according to these rules.

       The measures on the administration of the physicians, who are affiliated with drug stores and practice there, and the institutions of rehabilitation and health care, which are engaged in medical treatment, shall be formulated by the municipal administrative department of health separately.