Administrative Regulations on Medical Institutions (Revised in 2016)

Administrative Regulations on Medical Institutions (Revised in 2016)
Administrative Regulations on Medical Institutions (Revised in 2016)

Order of the State Council of the People's Republic of China No.666

February 6, 2016

(Promulgated by the order of the State Council of the People's Republic of China No.149 on February 26, 1994; and revised in accordance with the Decision of the State Council on Revising Certain Administrative Regulations on February 6, 2016)

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 48 Where a medical institution violates the provisions of Article 28 hereof and employs persons other than medical workers to engage in medical and health technical work, the health administrative department of the people's government at the county level or above shall order it to make corrections, and may impose a fine of less than CNY5,000; where the circumstance is serious, its License for Practicing of Medical Institutions shall be revoked.

Article 49 Where a medical institution violates the provisions of Article 32 hereof and issues false documents, the health administrative department of the people's government at the county level or above shall give a warning; if the case caused harmful consequences, the health administrative department of the people's government at the county level or above may impose a fine of less than CNY1,000; and administrative sanctions shall be imposed on direct responsible persons by the employers concerned or governmental agencies at a higher level.

Article 50 All confiscated properties and fines shall be handed in to the treasury.

Article 51 Where a party concerned disagrees with the decision of the administrative penalty, it may apply for administrative reconsideration or institute legal proceedings in accordance with the provisions of the national laws and regulations.
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