1. Regulation on the Administration of Medical Institutions (issued by Order No. 149 of the State Council of the People’s Republic of China on February 26, 1994 and effective on September 1, 1994), Chapter II (Articles 6-14). Article 6 The health administrative departments of the local people's governments at or above the county level shall, according to the population, medical resources, medical needs and the distribution of the existing medical institutions in their respective administrative regions, develop plans for the formation of medical institutions within their respective administrative regions. Organs, enterprises and public institutions may, according to the needs, form medical institutions and incorporate them into the plans for the formation of local medical institutions. Article 7 The local people's governments at or above the county level shall incorporate the plans for the formation of medical institutions into the local regional health development plans and overall plans for urban and rural construction and development. Article 8 The formation of medical institutions shall comply with the plans for the formation of medical institutions and the basic standards for medical institutions. The basic standards for medical institutions shall be developed by the health administrative department of the State Council. Article 9 To form a medical institution, an entity or individual shall be subject to the examination and approval of the health administrative department of the local people's government at or above the county level and obtain the written approval for the formation of medical institutions, before undergoing other formalities with relevant departments. Article 10 To apply for forming a medical institution, an applicant shall submit the following documents: (I) a written application for the formation; (II) a feasibility study report for the formation; and (III) a site selection report and the drawings of architectural design. Article 11 To form a medical institution, an entity or individual shall file an application for formation under the following provisions: (I) For a medical institution that has no sickbeds or has less than 100 sickbeds, an application shall be filed with the health administrative department of the people's government of the county where it is located. (II) For a medical institution or specialized hospital that has more than 100 sickbeds, an application shall be filed under the provisions of the health administrative department of the people's government at the provincial level. Article 12 The health administrative department of the local people's government at or above the county level shall, within 30 days of the date of accepting an application for formation, issue a written reply of approval or disapproval; and issue a written approval for the formation of an institution, where approval is granted. Article 13 The formation of medical institutions under the unified plan of the state shall be decided by the health administrative department of the State Council. Article 14 Organs, enterprises and public institutions that form out-patient departments, clinics and health clinics (stations) serving their employees according to the basic standards of the state for medical institutions shall submit the relevant materials to the health administrative departments of the people's governments of the county where they are located for recordation. 2. Detailed Rules for the Implementation of the Regulation on the Administration of Medical Institutions (Order No. 35 of the Ministry of Health, effective on September 1, 1994), Chapter II (Articles 8-24) and Chapter IV (Articles 40-50) Article 8 All provinces, autonomous regions and municipalities directly under the Central Government shall rationally allocate and use medical resources according to their local Plans for the Formation of Medical Institutions. The Plans for the Formation of Medical Institutions shall be developed by the local health administrative departments at or above the county level according to the Guiding Principles for the Plans for Formation of Medical Institutions, shall be submitted to the people's governments at the same level for approval upon review by the health administrative departments at the next higher level, and shall be issued and implemented within their respective administrative regions. The Guiding Principles for the Plans for Formation of Medical Institutions shall be separately developed. Article 9 Local health administrative departments at or above the county level shall, in accordance with the powers and procedures as prescribed in the Guiding Principles for the Plans for Formation of Medical Institutions, organize the implementation of the Plans for the Formation of Medical Institutions within their respective administrative regions, assess the implementation thereof on a regular basis, and report the assessment results to the health administrative departments at a next higher level and people's governments at the same level on an annual basis. Article 10 Medical institutions of all categories, forms of system of ownership, affiliations and service objects shall be formed in accordance with the local Plans for the Formation of Medical Institutions. Article 11 The division of the approval powers for the formation of general hospitals, traditional Chinese medicine hospitals, hospitals of traditional Chinese and Western medicine, hospitals of minority ethnic medicine, specialized hospitals, sanitariums, rehabilitation hospitals, maternal and child health care hospitals, first aid centers, clinic inspection centers, and specialist disease prevention and treatment institutions with no less than 100 sickbeds shall be prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government; and the formation of other medical institutions shall be approved by the health administrative departments at the county level. Article 12 Under one of the following circumstances, no application shall be filed for the formation of any medical institution: (I) An entity is unable to independently assume civil responsibilities. (II) An individual is serving a sentence or does not have full capacity for civil conduct. (III) Medical personnel of a medical institution are on the job, resign from office due to illness, or retain the job with suspension of salary. (IV) Medical personnel have had a medical malpractice above grade 2 for less than five years. (V) The practicing license of the medical personnel has been revoked due to violation of the relevant laws, regulations and rules. (VI) The legal representative or the primary person in charge of a medical institution is revoked of his Practicing License for A Medical Institution. (VII) Other circumstances as prescribed by the health administrative departments under the governments of the provinces, autonomous regions and municipalities directly under the Central Government. Any individual falling under the circumstances as prescribed in item (II), (III), (IV), (V) or (VI) of the preceding paragraph shall not act as the legal representative or the primary person in charge of any medical institution. Article 13 An individual who sets up a clinic in a city shall concurrently meet the following conditions: (I) He or she has passed the practicing examinations for physicians and has obtained the Physician's Practicing Certificate. (II) After obtaining the Physician's Practicing Certificate or physician's title, he or she has engaged in clinical work of the same profession for more than five years. (III) Other conditions as prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. The technical standards for physicians' practicing shall be separately developed. The conditions for individuals forming clinics in rural towns and villages shall be prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. Article 14 For the formation of medical institutions by the local people's governments at all levels, applications shall be filed by the persons in charge of the formation preparation of the to-be formed medical institutions as designated or appointed by the governments; for the formation of medical institutions by legal persons or other organizations, applications shall be filed by their representatives; for the formation of medical institutions by individuals, applications shall be filed by the persons who are to form the medical institutions; and the formation of medical institutions by two or more persons, applications shall be jointly filed by partners. Article 15 A Feasibility Study Report on the Formation as required by Article 10 of the Regulation to be submitted shall include the following contents: (I) the name and basic information of the application entity, and the applicant's name, age, professional resume and identity card number; (II) the population, economic and social development, and other profile of the region; (III) local people's health status, prevalence of diseases, and prevalence rate of relevant diseases; (IV) the distribution of medical resources in the area and the analysis on the demand for medical services; (V) the name, site selection, function, task and service radius of the medical institution to be formed; (VI) the service mode, time, diagnostic and treatment items, and bed establishment of the medical institution to be formed; (VII) the organizational structure and staffing of the medical institution to be formed; (VIII) the allocation of apparatus and equipment of the medical institution to be formed; (IX) the relationship between the medical institution to be formed and other medical institutions in the service radius area and the influence thereof; (X) the sewage, contaminating things and fecal treatment plan of the medical institution to be formed; (XI) the information on the communication, power supply, water supply and sewerage, and fire-fighting facilities of the medical institution to be formed; (XII) the sources of funds, investment method, total investment and registered capital (capital); (XIII) the investment budget for the medical institution to be formed; and (XIV) the predictive analysis on cost-effect of the medical institution to be formed within five years. And the credit certificate for the entity or individual applying for formation shall be annexed. Where an application is filed for forming outpatient departments, clinics, medical rooms, dispensaries, health centers, health stations, village health rooms (clinics), nursing stations and other medical institutions, the Feasibility Study Report on the Formation may be appropriately simplified in light of the actual circumstance. Article 16 A site selection report as required by Article 10 of the Regulation to be submitted shall include the following contents: (I) the basis for site selection; (II) the information on the environment and public facilities in the area where the site selected is located; (III) the relationship between the site selection and the layout of the surrounding nurseries and kindergartens, primary and secondary schools, and food production and operation entities; and (IV) the land occupied and the construction area. Article 17 Where two or more legal persons or other organizations jointly apply for the formation of a medical institution and two or more partners apply for the formation of a medical institution, besides submitting a feasibility study report and a site selection report, an agreement jointly signed by all parties shall also be submitted. Article 18 The construction of a medical institution may not commence until the architectural design thereof has passed examination by the approval authority. Article 19 The acceptance time of the application for formation as prescribed in Article 12 of the Regulation shall be counted from the date on which the applicant provides all the materials as specified in the Regulation and these Detailed Rules. Article 20 The local health administrative departments at or above the county level shall examine and approve the formation of medical institutions in accordance with the local Plans for the Formation of Medical Institutions and these Detailed Rules. An application for the formation of a medical institution falling under one of the following circumstances shall not be approved: (I) The local Plan for the Formation of Medical Institutions is not complied with. (II) The person who is to form the medical institution does not meet the conditions prescribed. (III) The credit certificate covering the total investment amount is unable to be provided. (IV) The total investment amount is unable to cover various budgetary expenditures. (V) The site selection for a medical institution is unreasonable. (VI) The sewage, contaminating things and fecal treatment plan is unreasonable. (VII) Other circumstances as prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. Article 21 The health administrative department shall, while issuing the Approval Certificate for the Formation of a Medical Institution, undergo the formalities of recordation with the health administrative department at the next higher level. A health administrative department at a higher level shall have the power to correct or revoke the approval for formation issued by the health administrative department at a lower level, which is not conforming to the local Plan for the Formation of Medical Institutions. Article 22 The term of validity of the Approval Certificate for the Formation of Medical Institutions shall be prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. Article 23 To change the category, size, site selection and diagnostic and treatment items of a medical institution as approved in the Approval Certificate for the Formation of Medical Institutions, a new application shall be filed for undergoing the formalities of approval for formation under the provisions of the Regulation and these Detailed Rules. Article 24 For outpatient departments, clinics and health clinics (stations) formed by legal persons and other organizations for serving internal employees, the formation entity shall, before the practicing registration of such a medical institution, undergo the recordation formalities with the local health administrative department at the county level and submit the following materials: (I) the decision of the formation entity or its competent department for the formation of a medical institution; and (II) the Recordation Form for the Formation of a Medical Institution; The health administrative department shall, within 15 days upon receipt of the recordation materials, issue a Recordation Receipt for the Formation of a Medical Institution. Article 40 A name of a medical institution shall consist of the identifiable name and general name in proper order. The general names of medical institutions include hospital, central public health center, health center, sanitarium, maternal and child health care hospital, outpatient department, clinic, medical room, health station, dispensary, health center, first aid center, first aid station, clinic inspection center, prevention and treatment hospital, prevention and control clinic, prevention and control station, nursing home, nursing station, nursing center, and other names as prescribed or accepted by the Ministry of Health. A medical institution may use the following name as the identifiable name: the name of a place, the name of an entity, the name of an individual, the name of a medical subject, the name of a medical and specialist profession, the name of a diagnostic and treatment item, and the name approved to be used by an approval authority. Article 41 A medical institution shall be named under the following principles: (I) The general name of a medical institution shall be limited to the names as listed in paragraph 2 of the preceding article. (II) The identifiable names of a medical institution as listed in paragraph 3 of the preceding article may be used together. (III) The name shall match the fact. (IV) The name shall be compatible with the category or diagnostic and treatment items of the medical institution. (V) The identifiable names of the medical institutions formed by the local people's governments at all levels shall include the names of the administrative divisions such as province, city, county, district, community, township, town and village, and the identifiable names of other medical institutions shall not include any name of any administrative division. (VI) The name of a medical institution formed by a state organ, enterprise and public institution, social organization or individual shall include the name of the forming entity or individual. Article 42 A medical institution shall not use any of the following names: (I) a name impairing the interests of the state, society and the public; (II) a name infringing upon the interests of others; (III) a name consisting of any foreign letters or Chinese pinyin; (IV) a name called after a medical equipment, drug, or medical product; (V) a name containing “difficult and complicated disease,” “specializing in,” “expert,” “famous doctor” or characters of similar meaning, or any other name publicizing or implying the diagnostic and treatment effect; (VI) a name beyond the scope of registered diagnostic and treatment items; or (VII) any other names prohibited to be used by the health administrative departments at or above the provincial level. Article 43 The following names of medical institutions shall be approved by the Ministry of Health and the names of the medical institutions of traditional Chinese medicine, medical institutions of traditional Chinese and Western medicine and medical institutions of minority ethnic medicine shall be approved by the State Administration of Traditional Chinese Medicine: (I) the names containing the names of foreign countries (regions) and abbreviations thereof, and names of the international organizations; (II) the names containing “China,” “whole country,” “Chunghwa,” “state” and other characters and cross-provincial geographical names; and (III) the identifiable names of the medical institutions formed by the local people's governments at all levels not containing the names of administrative divisions. Article 44 The names of medical institutions with the general name of “center” shall be approved by the health administrative departments at or above the provincial level; and the approval of the names of the medical institutions whose identifiable names contain the character of “center” shall be prescribed by the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. The names of medical institutions containing the character of “center” shall concurrently contain the names of administrative divisions or names of places. Article 45 Except specialist disease prevention and treatment institutions, medical institutions shall not use the names of specific diseases as the identifiable names and medical institutions that indeed have needs shall obtain the approval of the health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government. Article 46 The name of a medical institution may only be used after being approved and registered and after the Practicing License for a Medical Institution is obtained, and it shall enjoy the exclusive right to use the name within the jurisdiction of the approval authority. Article 47 A medical institution shall only be allowed to use one name. Where there is indeed need, two or more names may be used with the approval of the approval authority, but a first name shall be determined. Article 48 The health administrative department shall have the power to correct the inappropriate name of a medical institution that has been approved to be registered, and the health administrative department at a higher level shall have the power to correct the inappropriate name of a medical institution that has been approved by the health administrative department at a lower level to be registered. Article 49 Where two or more applicants apply to the same approval authority for the same name of a medical institution, the approval authority shall conduct verification under the principle of prior application. Where the applications are filed on the same day, it shall be settled through consultation by the two applicants; and where the consultation fails, the decision shall be made by the approval authority. Where two or more medical institutions have disputes as the names of medical institutions having been approved to be registered are identical, the approval authority shall handle it under the principle of prior registration. Where the formalities of registration are undergone on the same day, it shall be settled through consultation by the two parties; and where the consultation fails, the case shall be submitted by the approval authority to the health administrative department at a next higher level for decision-making. Article 50 No name of any medical institution shall be sold or lent. Without the permission of the approval authority, the name of a medical institution shall not be transferred. 3. Measures for the Administration of Medical Beauty Service (Order No. 19 of the Ministry of Health, PRC), Articles 5-7 Article 5 An applicant who applies for establishing a medical cosmetology institution or establishing a medical cosmetology department in the established medical institution shall concurrently meet the following conditions: (I) The applicant shall have the ability to bear civil liability; (II) The applicant shall have clear business scope of medical cosmetology; (III) The applicant shall have met the requirements of the Basic Standards for Medical Institutions (Trial); and (IV) The applicant shall have met other conditions specified by health administrative departments of the local people's governments at or above the provincial level. Article 6 Any institutional or individual applicant who applies for establishing a medical cosmetology institution shall complete the formation, approval, registration and recordation procedures specified herein and in the Regulations on the Administration of Medical Institutions and the Detailed Rules for the Implementation thereof. The health administrative department shall, within 30 days after receiving the qualified application materials, make a decision to approve or reject the application and send a written reply to the applicant. Article 7 When issuing a Written Approval for Forming A Medical Institution and a Practicing License for A Medical Institution, a health administrative department shall report it to its superior health administrative department. The superior health administrative department shall correct or repeal any approval decision made by the subordinate health administrative department within 30 days after it is aware that the decision has been made in violation of relevant regulations. 4. Procedures of Shanghai Municipality on the Administration of Medical Institutions, Chapter II (Articles 8-20) Article 8 (Planning for formation) The municipal health administrative department shall, according to national planning guidelines for the formation of medical institutions and actual situation of the municipality, develop its own municipal plan for the formation of medical institutions. After comprehensive balancing by the municipal planning management department, the plan shall be submitted to the municipal people’s government for approval, and the municipal people’s government will incorporate the plan into the municipal health development plan and overall urban plan. The health administrative departments at the district and county levels shall, according to the municipal plan for the formation of medical institutions and actual situation of their respective districts and counties, develop their own district and county plans for the formation of local medical institutions with the planning management departments. After reviewed and approved by the municipal health administrative department, the plans will be submitted to the district and county people’s governments for approval, and the district and county people’s governments will incorporate them into their respective district and county health development plans and detailed regional plans. Article 9 (Application for formation) To form a medical institution, the application shall be filed to the health administrative department. After it has been approved by the health administrative department, relevant procedures will be completed with other departments. Article 10 (Conditions for formation) To apply for forming a medical institution, the following conditions shall be met: (I) The municipal plan for the formation of medical institutions has been complied with; (II) The national basic standards for medical institutions have been complied with; (III) There is a suitable site for the formation; and (IV) There is necessary funding for the formation. Article 11 (Conditions for formation of an private clinic or nursing station) To apply for forming an individual (including partnership, the same below) clinic or nursing station, in addition to the conditions set out in Paragraphs (II) to (IV) of Article 10 hereof, the following conditions shall also be met: (I) The applicant shall be a permanent resident of the municipality; (II) The applicant has the professional qualifications as a doctor or nurse in conformity with the practicing scope applied for and a clinical experience of more than 5 years in the same profession; (III) The applicant is not an in-service employee. Article 12 (Restrictions on application) An entity which is unable to independently assume civil responsibilities shall not file an application for the formation of a medical institution. No application shall be filed for the formation of any medical institution by: (I) The person who is incapable of, or with restricted capacity of, doing a civil act; (II) The person who is serving a sentence liability or receiving reeducation through labor; (III) The in-service employee; (IV) The person who bears direct liability for a medical accident of Class II or above, which has not yet been 5 years; (V) The medical person whose certificate of practice is revoked; (VI) The original legal representative or the principal of a medical institution whose Practice License of Medical Institution has been revoked for less than 5 years; (VII) The person who is still suffering from an infections disease or other health problem, thus being unsuitable to be engaged in medical practicing activities; or (VIII) The person who has been dismissed from public office by the State organs or whose employment contract has been discharged by a medical institution for less than 5 years. Article 13 (Application materials to be submitted) The following materials shall be submitted on application for the formation of a medical institution, except for the application for forming a private clinic or e nursing station: (I) a written application for the formation; (II) a site selection report and the drawings of architectural design; (III) a feasibility study report; (IV) the certificates of credit standing and respectability of the applicant; and (V) basic information certificates of the applicant. Article 14 (Application materials to be submitted for the formation of a private clinic or nursing station) The following materials shall be submitted on application for the formation of a private clinic or nursing station: (I) a written application for the formation; (II) the certificate of house property right or the certificate of house use rights; and (III) all of the related certificates which fully prove that the applicant meets the requirements stipulated in Article 10 hereof. Article 15 (Grading of medical institutions) According to the national basic standards for grading medical institutions, hospitals (except convalescence hospital), women and children care center (station), and disease prevention and cure center (station) in Shanghai shall be graded into three grades: Grade III, Grade II and Grade I. Article 16 (Competence for examining and approving the formation) For the formation of the following medical institutions, an application shall be submitted to the municipal health administrative department: (I) Grade-III hospital, Grade-II hospital and convalescence hospital; (II) Sanatorium, women and children care center (station) and disease prevention and cure center (station); (III) Medical first-aid center (station); (IV) Clinical laboratory; and (V) Other medical institutions stipulated by the municipal health administrative department. For the formation of the following medical institutions, an application shall be submitted to the district or county health administrative department in the locality where the medical institution will be formed: (I) Grade-I hospital; (II) Out-patient department; (III) Clinic; (IV) Nursing center (station); and (V) Health center (station, post) and health-care station. Article 17 (Principles and procedures for examining and approving the formation) The health administrative department shall, according to the plan for the formation of medical institutions, the national basic standards for medical institutions, and the related provisions hereof, examine and approve the application for forming a medical institution. The health administrative department shall examine the application within 30 days after receipt of all the materials submitted by the applicant for forming a medical institution. The health administrative department shall approve and issue an Approval for Forming A Medical Institution to the applicant if the application meets the requirements, or inform the applicant in writing if the application does not meet the requirements. Before examining and issuing the Approval for Forming A Medical Institution, the district or county health administrative department shall inform the applicant of going through the formalities for the name ratification of the medical institution with the municipal health administrative department; and the municipal health administrative department shall reply in writing within 10 days after receiving the written application for the name ratification. During the name ratification period, the procedure of examination and approval of the formation shall be suspended. The district or county health administrative department shall submit the Approval for Forming A Medical Institution to the municipal health administrative department for record within 15 days after its issuance. The municipal health administrative department has the right to rectify or cancel the approval decision made by the district or county health administrative department which does not conform to the stipulations hereof. Article 18 (Validity period of the written approval) According to the different grades of medical institutions, the validity period of the Approval for Forming A Medical Institution shall respectively be as follows: (I) Two years for hospitals, sanatorium, women and children care center (station), disease prevention and cure center (station), medical first-aid center and clinical laboratory; (II) One year for outpatient department, medical first-aid station and nursing center; and (III) Six months for clinic, nursing station, health center (station, post), and health-care station. Article 19 (Procedures for examining and approving alteration and re-formation and for examining and approving the formation of branches) Before the registration of practice of a medical institution, if the ratified name or medical subjects of diagnosis and treatment are changed, the institution shall apply for examination and approval for the change. Before the registration of practice of a medical institution, if the ratified classification, number of sickbeds, address, or the establishment applicant is changed, the institution shall re-apply for the formation examination and approval. If a medical institution intends to form a branch, it shall apply for examination and approval with the original health administrative department which has examined and approved the formation of the medical institution. If the branch is not formed in the district or county where the medical institution is located, the formation of the branch shall obtain the consent from the district or county health administrative department in the locality where the branch shall be formed. Article 20 (Architectural design) The architectural design of medical institutions shall conform to the architectural specification, design standards and other relevant stipulations and standards for medical institutions stipulated by the state. The architectural project of medical institutions shall not be constructed until the design scheme and initial extension design are examined and approved by the original health administrative department which has examined and approved the formation of the medical institution and the Planning Permit of the Construction Project is issued by the planning department. 5. Interim Measures for the Administration of Hong Kong and Macao Service Providers' Establishment of Sole Proprietorship Hospitals in the Mainland, Chapters II and III Article 8 The establishment and development of Hong Kong and Macao sole proprietorship hospitals shall conform to the local planning for the setup of medical institutions. Article 9 A Hong Kong and Macao service provider applying for the establishment of Hong Kong and Macao sole proprietorship hospitals shall be a legal person that can independently assume civil liabilities and shall have directly or indirectly made investments in medical treatment and public health and have the management experience thereof, and shall meet any of the following requirements: (I) It can provide advanced experiences and hospital management and service modes; or (II) It can provide internationally advanced medical technologies. Article 10 The Hong Kong and Macao sole proprietorship hospitals to be established shall meet the following requirements: (I) It must be an independent legal person; (II) The total investment shall not be less than RMB 50,000,000 for Level Three hospitals, and the total investment shall not be less than RMB 20,000,000 for Level Two hospitals; (III) It shall meet the basic standards for hospitals at or above Level Two; and (IV) The requirement of total investment for Hong Kong and Macao sole proprietorship hospitals established in old revolutionary base areas, border areas, poverty-stricken areas and ethnic minority areas may be properly lowered. Article 11 For the establishment of a Hong Kong and Macao sole proprietorship hospital, an applicant shall file an application with the health administrative department at the level of the districted city at the locality of the hospital, and the following materials shall be submitted: (I) An application for the establishment of a medical institution; (II) A project proposal; (III) A feasibility study report; (IV) Certification of the Hong Kong and Macao service provider; (V) A registration certificate of legal person (photocopy), identity certificate of the legal representatives (photocopy) and certificate of credit worthiness issued by a bank; (VI) A report on site selection for a project, rental certificate of the land use of the project, architectural plan of the project; and (VII) The certification materials that Hong Kong and Macao service providers can provide internationally advanced experiences and modes of hospital management and service; or have internationally advanced medical technologies. Article 12 The health administrative department at the level of the districted city shall make a preliminary examination on the materials submitted by the applicant, and shall issue preliminary examination opinions according to the plans for the setup of medical institutions. The preliminary examination opinions, together with the application materials for the establishment of hospitals and the local plans for the setup of medical institutions shall be reported by the said health administrative department to the health administrative department at the provincial level for approval. Article 13 The health administrative department at the provincial level shall verify the application materials and the preliminary examination opinions of the health administrative department at the level of the districted city, put forward its opinions, and report them all to the Ministry of Health for examination and approval. The following materials shall be submitted by the health administrative department at the provincial level to the Ministry of Health for examination and approval: (I) Application materials of the applicant; (II) Plan for the Setup of Medical Institutions approved by the people's government at the level of the districted city at the locality where the hospital is to be located for promulgation and implementation, and opinions of the health administrative departments at the level of the districted city and at provincial level about whether the establishment of the Hong Kong and Macao sole proprietorship hospital is in conformity with the local plan for the setup of medical institutions; (III) Opinions of the health administrative department at the provincial level concerning the establishment of the Hong Kong and Macao sole proprietorship hospital, including opinions about the title, site, scale (sickbeds, dental chairs), diagnosis and treatment subjects; and (IV) Other materials as required by laws, regulations and provisions of the Ministry of Health. The Ministry of Health shall decide in written form whether to approve or disapprove the project within 20 days after accepting the materials mentioned above. Article 14 An application for establishing a Hong Kong and Macao sole proprietorship hospital of traditional Chinese medicine (including hospital of traditional Chinese and western medicine and hospital of minority ethnic medicine) shall, in accordance with the requirements of Articles 11, 12 and 13 of these Interim Measures, be subject to the preliminary examination of the traditional Chinese medicine administrative department of the city where the hospital is to be located, the verification of the traditional Chinese medicine administrative department at the provincial level of the jurisdiction and the verification of the State Administration of Traditional Chinese Medicine and to the final examination and approval of the Ministry of Health. Article 15 After obtaining the approval of the Ministry of Health for establishment, the applicant for establishing a for-profit Hong Kong and Macao sole proprietorship hospital shall, in accordance with the provisions of relevant laws and regulations, file an application with the Ministry of Commerce and submit the following materials: (I) Application materials and the approval document; (II) Bylaws of the Hong Kong and Macao sole proprietorship hospital; (III) Lists of persons selected as the legal representative or members of the board of directors of the Hong Kong and Macao sole proprietorship hospital; (IV) Notice of prior approval of institutional titles issued by the administration for industry and commerce; and (V) Other materials required by laws, regulations and provisions of the Ministry of Commerce. The Ministry of Commerce shall, within 20 days after accepting the application, decide in written form whether to approve or disapprove the establishment; if it is to make a decision of approval, a Certificate of Approval of Foreign-funded Enterprises shall be issued. If it is to make a decision of disapproval, it shall provide reasons. The approved Hong Kong and Macao sole proprietorship hospital shall, within one month after receiving the Certificate of Approval of Foreign-funded Enterprises issued by the Ministry of Commerce, go through the formalities for registration at the relevant department by presenting the Certificate pursuant to law. Article 16 After obtaining the approval of the Ministry of Health for establishment, the applicant for establishing a not-for-profit Hong Kong and Macao sole proprietorship hospital shall, via the website of Foreign Investment Examination and Approval Management System of the Ministry of Commerce, fill in the Filing Form of Foreign-funded Not-for-profit Medical Institutions, submit the following materials and go through the filing formalities at the Ministry of Commerce: (I) “Printed Version (signed and sealed)” of the Filing Form of Foreign-funded Not-for-profit Medical Institutions; and (II) The approval document of the health department (photocopy). The Ministry of Commerce shall put them on records and affix its official seal to the Filing Form of Foreign-funded Not-for-profit Medical Institutions. Article 17 The approved Hong Kong and Macao sole proprietorship hospital shall, according to the provisions of the Regulations on the Administration of Medical Institutions and the Detailed Rules for the Implementation thereof concerning the procedure and requirements for the registration of medical institutions, apply to the local health administrative department at the provincial level for business registration and for a Business License of Medical Institutions. Article 18 The title of the Hong Kong and Macao sole proprietorship hospital shall consist sequentially of the name of the place where the hospital is to be located, the identification name and the common name and shall meet the relevant provisions on the naming of medical institutions. Article 19 An approved Hong Kong and Macao sole proprietorship hospital shall complete the registration formalities within the period provided by the approving authority; where it fails to complete the formalities, the sole proprietorship hospital project shall be cancelled upon the approval of the approving authority. Article 20 Where an existing Hong Kong and Macao sole proprietorship hospital alters its title, site, scale (sickbeds, dental chairs), diagnosis and treatment subjects, total investment or registered capital, it shall, after obtaining approval from the original approving authority in accordance with the approval procedure as prescribed in this Chapter, go through corresponding alteration registration procedures at the original project registration authority. Article 21 Where an existing Hong Kong and Macao sole proprietorship hospital applies for alteration of the establisher or stock equity, it shall respectively report to the Ministry of Health and the Ministry of Commerce for approval in accordance with the provisions of these Interim Measures. Article 22 Where an existing Hong Kong and Macao sole proprietorship hospital terminates its operation, it shall commence the cancellation formalities 90 days before the termination. 6. Interim Measures for the Administration of Taiwan Service Providers' Establishment of Sole Proprietorship Hospitals in the Mainland, Chapters II and III Article 8 The establishment and development of Taiwan sole proprietorship hospitals shall conform to the local planning for the setup of medical institutions. Article 9 A Taiwan service provider applying for the establishment of Taiwan sole proprietorship hospitals shall be a legal person that can independently assume civil liabilities and shall have directly or indirectly made investments in medical treatment and public health and have the management experience thereof, and shall meet any of the following requirements: (I) It can provide advanced experiences and hospital management and service modes; or (II) It can provide internationally advanced medical technologies. Article 10 The Taiwan sole proprietorship hospitals to be established shall meet the following requirements: (I) It must be an independent legal person; (II) The total investment shall not be less than RMB 50,000,000 for Level Three hospitals, and the total investment shall not be less than RMB 20,000,000 for Level Two hospitals; (III) It shall meet the basic standards for hospitals at or above Level Two; and (IV) The requirement of total investment for Taiwan sole proprietorship hospitals established in old revolutionary base areas, border areas, poverty-stricken areas and ethnic minority areas may be properly lowered. Article 11 For the establishment of a Taiwan sole proprietorship hospital, an applicant shall file an application with the health administrative department at the level of the districted city at the locality of the hospital, and the following materials shall be submitted: (I) An application for the establishment of a medical institution; (II) A project proposal; (III) A feasibility study report; (IV) Valid certification of the Taiwan service provider; (V) A registration certificate of legal person (photocopy), identity certificate of the legal representatives (photocopy) and certificate of credit worthiness issued by a bank; (VI) A report on site selection for a project, rental certificate of the land use of the project, architectural plan of the project; and (VII) The certification materials that Taiwan service providers can provide internationally advanced experiences and modes of hospital management and service; or have internationally advanced medical technologies. Article 12 The health administrative department at the level of the districted city shall make a preliminary examination on the materials submitted by the applicant, and shall issue preliminary examination opinions according to the plans for the setup of medical institutions. The preliminary examination opinions, together with the application materials for the establishment of hospitals and the local plans for the setup of medical institutions shall be reported by the said health administrative department to the health administrative department at the provincial level for approval. Article 13 The health administrative department at the provincial level shall verify the application materials and the preliminary examination opinions of the health administrative department at the level of the districted city, put forward its opinions, and report them all to the Ministry of Health for examination and approval. The following materials shall be submitted by the health administrative department at the provincial level to the Ministry of Health for examination and approval: (I) Application materials of the applicant; (II) Plan for the Setup of Medical Institutions approved by the people's government at the level of the districted city at the locality where the hospital is to be located for promulgation and implementation, and opinions of the health administrative departments at the level of the districted city and at provincial level about whether the establishment of the Taiwan sole proprietorship hospital is in conformity with the local plan for the setup of medical institutions; (III) Opinions of the health administrative department at the provincial level concerning the establishment of the Taiwan sole proprietorship hospital, including opinions about the title, site, scale (sickbeds, dental chairs), diagnosis and treatment subjects; and (IV) Other materials as required by laws, regulations and provisions of the Ministry of Health. The Ministry of Health shall decide in written form whether to approve or disapprove the project within 20 days after accepting the materials mentioned above. Article 14 An application for establishing a Taiwan sole proprietorship hospital of traditional Chinese medicine (including hospital of traditional Chinese and western medicine and hospital of minority ethnic medicine) shall, in accordance with the requirements of Articles 11, 12 and 13 of these Interim Measures, be subject to the preliminary examination of the traditional Chinese medicine administrative department of the city where the hospital is to be located, the verification of the traditional Chinese medicine administrative department at the provincial level of the jurisdiction and the verification of the State Administration of Traditional Chinese Medicine and to the final examination and approval of the Ministry of Health. Article 15 After obtaining the approval of the Ministry of Health for establishment, the applicant for establishing a for-profit Taiwan sole proprietorship hospital shall, in accordance with the provisions of relevant laws and regulations, file an application with the Ministry of Commerce and submit the following materials: (I) Application materials and the approval document; (II) Bylaws of the Taiwan sole proprietorship hospital; (III) Lists of persons selected as the legal representative or members of the board of directors of the Taiwan sole proprietorship hospital; (IV) Notice of prior approval of institutional titles issued by the administration for industry and commerce; and (V) Other materials required by laws, regulations and provisions of the Ministry of Commerce. The Ministry of Commerce shall, within 20 days after accepting the application, decide in written form whether to approve or disapprove the establishment; if it is to make a decision of approval, a Certificate of Approval of Foreign-funded Enterprises shall be issued. If it is to make a decision of disapproval, it shall provide reasons. The approved Taiwan sole proprietorship hospital shall, within one month after receiving the Certificate of Approval of Foreign-funded Enterprises issued by the Ministry of Commerce, go through the formalities for registration at the relevant department by presenting the Certificate pursuant to law. Article 16 After obtaining the approval of the Ministry of Health for establishment, the applicant for establishing a not-for-profit Taiwan sole proprietorship hospital shall, via the website of Foreign Investment Examination and Approval Management System of the Ministry of Commerce, fill in the Filing Form of Foreign-funded Not-for-profit Medical Institutions, submit the following materials and go through the filing formalities at the Ministry of Commerce: (I) “Printed Version (signed and sealed)” of the Filing Form of Foreign-funded Not-for-profit Medical Institutions; and (II) The approval document of the health department (photocopy). The Ministry of Commerce shall put them on records and affix its official seal to the Filing Form of Foreign-funded Not-for-profit Medical Institutions. Article 17 The approved Taiwan sole proprietorship hospital shall, according to the provisions of the Regulations on the Administration of Medical Institutions and the Detailed Rules for the Implementation thereof concerning the procedure and requirements for the registration of medical institutions, apply to the local health administrative department at the provincial level for business registration and for a Business License of Medical Institutions. Article 18 The title of the Taiwan sole proprietorship hospital shall consist sequentially of the name of the place where the hospital is to be located, the identification name and the common name and shall meet the relevant provisions on the naming of medical institutions. Article 19 An approved Taiwan sole proprietorship hospital shall complete the registration formalities within the period provided by the approving authority; where it fails to complete the formalities, the sole proprietorship hospital project shall be cancelled upon the approval of the approving authority. Article 20 Where an existing Taiwan sole proprietorship hospital alters its title, site, scale (sickbeds, dental chairs), diagnosis and treatment subjects, total investment or registered capital, it shall, after obtaining approval from the original approving authority in accordance with the approval procedure as prescribed in this Chapter, go through corresponding alteration registration procedures at the original project registration authority. Article 21 Where an existing Taiwan sole proprietorship hospital applies for alteration of the establisher or stock equity, it shall respectively report to the Ministry of Health and the Ministry of Commerce for approval in accordance with the provisions of these Interim Measures. Article 22 Where an existing Taiwan sole proprietorship hospital terminates its operation, it shall commence the cancellation formalities 90 days before the termination. ? 7. Notice of the Ministry of Health on Implementing Medical Service Issues Related in the Supplements IV to Mainland and Hong Kong/Macao Closer Economic Partnership Arrangements The health departments (bureaus) and the administrative bureaus of traditional Chinese medicine in all provinces, autonomous regions and municipalities directly under the Central Government, the health bureau of Sinkiang Production and Construction Corps: In order to implement the Supplements IV to Mainland and Hong Kong/Macao Closer Economic Partnership Arrangements, we hereby, in accordance with the related provisions of the Law on Medical Practitioners and the Regulation on the Administration of Medical Institutions, notify issues concerning opening private clinics in the mainland by qualified permanent residents of Hong Kong/Macao (hereinafter referred to as Hong Kong/Macao service providers) as follows: I. A Hong Kong/Macao service provider with the Medical Practitioner Certificate of the mainland (in clinic, traditional Chinese medicine or oral cavity) may open a private clinic in the mainland if he satisfies one of the following conditions: (I) having the legal right to practice medicine in Hong Kong/Macao, having been practicing medicine in Hong Kong/Macau for five years or more, or having been practicing medicine in both Hong Kong and Macao for accumulatively five consecutive years or more; or (II) having been doing the clinical work of the same specialty in the mainland for five consecutive years or more. II. One Hong Kong/Macao service provider may only open one private clinic in the mainland, which shall be fully funded by the service provider. He shall also be the person in charge of the clinic. III. A Hong Kong/Macao service provider who opens a private clinic in the mainland shall be registered and practice at the clinic. If he can't continue practicing at the clinic for reasons, he shall handle the relevant formalities to deregister the private clinic. IV. For a Hong Kong/Macao service provider who intends to open a private clinic in the mainland, the applied-for clinical subjects shall conform to his scope of work in the mainland and Hong Kong/Macao. V. In principle, a private clinic may not hire other medical practitioner. For medical needs, it is allowed to hire one or two medical practitioners (residents of the mainland) who shall have the same scope of work as the Hong Kong/Macao service provider. A private clinic may, in light of medical needs, hire a proper amount of nurses registered in the mainland. VI. In principle, the name of the private clinic opened by a Hong Kong/Macao service provider in the mainland shall be “name of its place + name of the Hong Kong/Macao service provider + medical department + clinic.” VII. To open a private clinic, a Hong Kong/Macao service provider shall apply to the health administrative department at the level of municipality divided into districts of the place where the clinic is to be located upon the strength of the relevant certificate and material, and the application shall be submitted to the health administrative department at the provincial level for examination and approval after passing the preliminary examination. The provincial health administrative department shall issue a written Approval for Forming A Medical Institution and report it to the Ministry of Health for archival purpose. To open a private traditional Chinese medicine clinic, a Hong Kong/Macao service provider shall file an application with the health administrative department at the level of municipality divided into districts for preliminary examination, and the health administrative department shall, if the application passes the preliminary examination, file it with the administrative department of traditional Chinese medicine at the provincial level for examination and approval, which shall issue a written Approval for Forming A Medical Institution and report it to the State Administration of Traditional Chinese Medicine and the Ministry of Health for archival purpose. The registration as well as daily supervision and administration of private clinics shall be governed by the provisions of the health administrative department and the administrative department of traditional Chinese medicine at the provincial level. VIII. A Hong Kong/Macao service provider shall submit the following certificates and materials in addition to the application materials specified in the Regulation on the Administration of Medical Institutions and the Detailed Rules for the Implementation of the Regulation: (I) the Medical Practitioner Certificate of the mainland (the original and a photocopy); (II) the medical practice certificate, license or registration certificate of Hong Kong/Macao (the original and a photocopy) recognized by the Medical Council of Hong Kong, the Dental Council of Hong Kong, the Chinese Medicine Council of Hong Kong or the Department of Health of Macao; (III) a medical liability insurance certificate (the original) which covers the mainland, issued by an insurance institution of the mainland or Hong Kong/Macao; and (IV) a professional ethics or good reputation certificate of Hong Kong/Macao (the original) issued by the Medical Council of Hong Kong, the Dental Council of Hong Kong, the Chinese Medicine Council of Hong Kong or the Department of Health of Macao; or a practice experience certificate (the original) and the Certificate to Practice as a Medical Practitioner (a photocopy) issued by the health administrative department at the level of municipality divided into districts. IX. Private clinics established by Hong Kong/Macao service providers shall be run in accordance with the related laws and regulations governing medical institutions of the mainland, medical technology, medical practitioners and practicing nurses as well as the principles of guaranteeing medical treatment quality and safety. Medical malpractices or disputes over medical treatment occurred in such clinics shall be handled in accordance with the related provisions of the mainland. X. This Notice shall come into trial implementation on January 1, 2008. 8. Notice on Matters Concerning the Implementation of Supplement VII to the Mainland and Hong Kong/Macao Closer Economic Partnership Arrangement The health departments and commerce departments of all provinces, autonomous regions and municipalities directly under the Central Government; and the Health Bureau and Commerce Bureau of Xinjiang Production and Construction Corps: To promote the establishment of closer economic partnership between Hong Kong, Macao and the Mainland of China and implement the Supplement VII to the Mainland and Hong Kong Closer Economic Partnership Arrangement and the Supplement VII to the Mainland and Macao Closer Economic Partnership Arrangement as approved by the State Council, relevant matters are hereby announced: I. “The total investment amount for Hong Kong and Macao service providers to establish equity joint and cooperative joint medical institutions within the territory of China shall be no less than ten million yuan” in the Supplementary Provisions to the Interim Measures for the Administration of Sino-foreign Equity Joint and Cooperative Joint Medical Institutions, is amended to “the total investment amount for Hong Kong and Macao service providers to establish equity joint and cooperative joint medical institutions within the territory of China shall be no less than ten million yuan, except that an applicant applies for establishing a equity joint or cooperative joint medical institution in Guangdong Province, in which case there shall be no requirement on the total investment amount”. II. There is no proportion limit for Hong Kong and Macao service providers to apply for establishing equity joint and cooperative joint medical institutions in Shanghai, Fujian, Guangdong, Hainan and Chongqing. III. Where a Hong Kong or Macao service provider applies for establishing a equity joint or cooperative joint medical institution in Guangdong, the provincial-level health administrative department of Guangdong Province (including the administrative department for traditional Chinese medicine) shall be responsible for application approval and practicing licensing functions of the health department. The review and approval functions of the commerce department shall be performed according to relevant provisions. IV. Hong Kong and Macao service providers are allowed to establish wholly-owned, equity joint and cooperative joint medical institutions in Guangdong and provide medical services. V. Where Hong Kong and Macao service providers apply for establishing wholly-owned medical institutions in Shanghai, Fujian, Guangdong, Hainan and Chongqing, and where legally registered medical and health workers come from Hong Kong and Macao to the Mainland for short-term practice, applicable laws and regulations as well as relevant provisions shall apply. This Notice shall come into force on January 1, 2011. 9. Notice on Expanding the Territorial Scope for Hong Kong and Macao Service Suppliers to Establish Wholly-Owned Hospitals in the Mainland The health departments (or bureaus) and commerce departments of all provinces, autonomous regions, and municipalities directly under the Central Government; the commerce departments of all cities under separate state planning; and the Health Bureau and Commerce Bureau of Xinjiang Production and Construction Corps: In accordance with the Supplement VIII to the Mainland and Hong Kong Closer Economic Partnership Arrangement and the Supplement VIII to the Mainland and Macao Closer Economic Partnership Arrangement, from April 1, 2012, the territorial scope for Hong Kong and Macao service suppliers to establish wholly-owned hospitals in the mainland, which now includes Shanghai, Chongqing, Guangdong, Fujian, and Hainan, will be expanded to include all municipalities directly under the Central Government and capital cities of all provinces (or autonomous regions). The specific measures for establishing wholly-owned hospitals shall be governed by the Interim Measures for the Administration of Hong Kong and Macao Service Suppliers' Establishment of Wholly-Owned Hospitals in the Mainland (No. 109 [2010] of the Ministry of Health). ? 10. Notice of the Ministry of Health and the Ministry of Commerce on Issues concerning the Establishment of Medical Institutions in the Mainland by Hong Kong and Macao Service Providers The health departments (bureaus) and commerce departments of all provinces, autonomous regions, and municipalities directly under the Central Government; the Health Bureau and Commerce Bureau of the Xinjiang Production and Construction Corps; and the commerce departments of all cities under separate state planning: In accordance with the Supplement IX to the Mainland and Hong Kong Closer Economic Partnership Arrangement and the Supplement IX to the Mainland and Macao Closer Economic Partnership Arrangement, you are hereby notified of the issues concerning the establishment of medical institutions in the Mainland by Hong Kong and Macao service providers as follows: I. Hong Kong and Macao service providers shall be permitted to establish medical institutions in the Mainland in the form of sole proprietorship or of equity or cooperative joint venture with medical institutions, companies, enterprises or other economical organizations of the Mainland. II. Hong Kong and Macao service providers shall establish equity or cooperative joint venture medical institutions or wholly-owned medical institutions other than wholly-owned hospitals and wholly-owned sanatoriums in the Mainland in accordance with the standards and requirements concerning the establishment of medical institutions by entities or individuals of the Mainland. III. The establishment of equity or cooperative joint venture medical institutions or wholly-owned medical institutions other than wholly-owned hospitals and wholly-owned sanatoriums in the Mainland by Hong Kong and Macao service providers shall be subject to the examination and approval of provincial health administrative departments. IV. The provincial health administrative department of Guangdong Province shall be responsible for the examination and approval of the establishment of wholly-owned hospitals in Guangdong Province by Hong Kong and Macao service providers. V. The aforesaid Provisions shall come into force on January 1, 2013. 11. Notice of the National Health and Family Planning Commission on Adjusting the Examination and Approval Power for Establishment of Wholly-Owned Hospitals in the Mainland by Service Suppliers from Hong Kong, Macao or Taiwan The health departments and bureaus (health and family planning commissions) of all provinces, autonomous regions and municipalities directly under the Central Government; and the Health Bureau of Xinjiang Production and Construction Corps: In accordance with the Provisions on the Main Functions, Internal Bodies and Staffing of the National Health and Family Planning Commission (No. 50 [2013] of the General Office of the State Council) issued by the General Office of the State Council, pursuant to the Administrative License Law, the Regulation on the Administration of Medical Institutions and other relevant provisions, the National Health and Family Planning Commission (“NHFPC”) has decided to delegate the examination and approval power for establishment of wholly-owned hospitals in the mainland by service suppliers from Hong Kong, Macao or Taiwan to departments of health (health and family planning) administration at the provincial level. You are hereby notified of the relevant matters as follows: I. Where a service supplier from Hong Kong, Macao or Taiwan intends to establish a wholly-owned hospital in the mainland, upon preliminary examination of the department of health administration at the level of the districted city where the hospital is to be located, the matter shall be submitted to the department of health and family planning administration at the provincial level for examination and approval. II. Where establishment of a wholly Hong Kong/Macao/Taiwan-owned hospital has been approved by the NHFPC and the Ministry of Commerce but there is a change in the founder, legal representative, address, total investment, scale (hospital beds, dental chairs), diagnostic and treatment items, and time limit for preparation for formation, upon the preliminary examination of the department of health administration at the level of the districted city where the hospital is located, the matter shall be submitted to the department of health and family planning administration at the provincial level for examination and approval. III. After a department of health and family planning administration at the provincial level approves the establishment, change, closedown or other matters concerning a wholly Hong Kong/Macao/Taiwan-owned hospital, the applicant shall file an application with the corresponding competent commerce department in accordance with the relevant laws and regulations. IV. A service supplier from Hong Kong, Macao or Taiwan shall apply for the establishment of a wholly-owned hospital in accordance with the Interim Measures for the Administration of Establishment of Wholly-Owned Hospitals in the Mainland by Service Suppliers from Hong Kong or Macao (No. 109 [2010] of the Ministry of Health), the Interim Measures for the Administration of Establishment of Wholly-Owned Hospitals in the Mainland by Service Suppliers from Taiwan (No. 110 [2010] of the Ministry of Health), the Notice on Expanding the Territorial Scope for Hong Kong and Macao Service Suppliers to Establish Wholly-Owned Hospitals in the Mainland (No. 19 [2012] of the Ministry of Health), the Notice on Issues concerning the Establishment of Medical Institutions in the Mainland by Service Suppliers from Hong Kong or Macao (No. 72 [2012] of the Ministry of Health) and other relevant provisions. V. Departments of health and family planning administration at the provincial level shall submit approvals of establishment of wholly Hong Kong/Macao/Taiwan-owned hospitals to the NHFPC for recordation. All regions shall contact the Medical Administration Bureau of the NHFPC in a timely manner for relevant problems encountered in the examination and approval of the establishment of wholly Hong Kong/Macao/Taiwan-owned hospitals.