Administrative Regulations on Medical Institutions

Administrative Regulations on Medical Institutions
Administrative Regulations on Medical Institutions

Order of the State Council [1994] No.149

February 26, 1994

Chapter I General Provisions

Article 1 The Administrative Regulations on Medical Institutions (hereinafter referred to as the "Regulations") are hereby formulated in order to strengthen the administration over medical institutions, promote the development of medical and health undertakings and protect the health of citizens.

Article 2 The Regulations apply to medical institutions such as hospitals, health centers, sanatoriums, out-patient departments, clinics and health posts (rooms) as well as first-aid stations engaging in disease diagnosis and treatment activities.

Article 3 Medical institutions aim to heal the wounded and rescue the dying, prevent and cure diseases and provide services for health of citizens.

Article 4 The State supports the development of medical institutions and encourages setting up medical institutions in various forms.

Article 5 The health administrative department under the State Council is responsible for the supervision and administration over medical institutions nationwide.
Health administrative departments of local people's governments at the county level or above are responsible for the supervision and administration over medical institutions within their respective administrative regions.
The competent health department of the Chinese People's Liberation Army shall, in accordance with the relevant provisions of the Regulations and the State, carry out supervision and administration over military medical institutions.

Chapter II Planning, Layout and Examination and Approval of the Setup

Article 6 The health administrative department of a local people's government at the county level or above shall, according to the population, medical resources, medical needs and the distribution of existing medical institutions within its administrative region, develop a plan for setting up medical institutions within its administrative region.
Governmental agencies, enterprises and public institutions may set up medical institutions according to their needs, and such medical institutions shall be included into the local plan for setting up medical institutions.

Article 7 Local people's governments at the county level or above shall include the plan for setting up medical institutions into the local regional health development plan and the overall planning for urban and rural construction and development.

Article 8 The setup of medical institutions shall comply with the plan for setting up medical institutions and the basic standards for medical institutions.
The basic standards for medical institutions shall be prepared by the health administrative department under the State Council.

Article 9 Where an entity or individual sets up a medical institution, the entity or individual must go through the examination and approval procedures with the health administrative department of the local people's government at the county level or above, and may handle other formalities with the relevant departments only after obtaining the approval letter on the setup of a medical institution.

Article 10 To apply for setting up a medical institution, the following documents shall be submitted:
1. the application for the setup;
2. the feasibility study report on the setup; and
3. the report on site selection and the architectural design plan.

Article 11 An entity or individual setting up a medical institution shall submit an application for the setup in accordance with the following provisions:
1. for medical institutions with no bed or with less than 100 beds, the entity or individual shall apply to the health administrative department of the people's government at the county level in the place where the medical institution is located; and
2. for medical institutions and special hospitals with 100 beds or more, the entity or individual shall make an application in accordance with the provisions of the health administrative department of the people's government at the provincial level.

Article 12 Health administrative departments of local people's governments at the county level or above shall, within 30 days upon the acceptance of the application for the setup, give a written reply of approval or refusal; where the application is approved, an approval letter on the setup of a medical institution shall be granted.

Article 13 The setup of medical institutions uniformly planned by the State shall be decided by the health administrative department under the State Council.

Article 14 Where governmental agencies, enterprises and public institutions set up out-patient departments, clinics, and health posts (rooms) to provide services for their employees in accordance with the basic national standards for medical institutions, they shall file the setup for record with the health administrative departments of the people's governments at the county level in the places where the medical institutions are located.

Chapter III Registration

Article 15 Medical institutions must be registered for practice, and obtain the License for Practicing of Medical Institutions.

Article 16 To apply for practice registration of medical institutions, a medical institution shall meet the following conditions:
1.
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