Regulation on the Administration of Medical Institutions (2016 Revision)

Regulation on the Administration of Medical Institutions (2016 Revision) Regulation on the Administration of Medical Institutions (Promulgated by the Order No. 149 of the State Council of the People's Republic of China on February 26, 1994; and revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on February 6, 2016) Chapter I General Provisions Article 1 This Regulation is developed for purposes of strengthening the administration of medical institutions, promoting the development of the medical and health cause, and protecting the health of citizens. Article 2 This Regulation shall apply to hospitals, health centers, nursing homes, out-patient departments, clinics, health clinics (stations), first aid stations and other medical institutions engaging in the diagnosis and treatment of diseases. Article 3 Medical institutions aim at retrieving the dying or rescuing the wounded, preventing and curing disease, and serving for the health of citizens. Article 4 The state shall support the development of medical institutions and encourage the establishment of medical institutions in various forms. Article 5 The health administrative department of the State Council shall be responsible for the supervision and administration of the medical institutions across the country. The health administrative departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of the medical institutions within their respective administrative regions. The competent health department of the Chinese People's Liberation Army shall, under this Regulation and the relevant provisions of the state, implement supervision and administration of the medical institutions of the Army. Chapter II Approval for Planning Layout and Formation 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. Article 10 To apply for forming a medical institution, an applicant shall submit the following documents: (1) a written application for the formation; (2) a feasibility study report for the formation; and (3) 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: (1) 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. (2) 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. Chapter III Registration Article 15 A medical institution providing relevant services shall conduct registration and obtain the Practicing License for a Medical Institution. Article 16 To apply for practicing registration, a medical institution shall meet the following conditions: (1) It has a written approval for the formation of a medical institution. (2) It complies with the basic standards for medical institutions. (3) It has an appropriate name, organizing institution and place. (4) It has funds, facilities, equipment and professional health technical personnel that are compatible with the business carried out. (5) It has corresponding rules and regulations. (6) It is able to independently assume civil responsibilities. Article 17 The practicing registration of medical institutions shall be handled by the health......