Regulations on the Administration of Medical Institutions (Revised in 2022)

Chapter I. General Provisions Article 1 These regulations are formulated to strengthen the management of medical institutions, promote the development of medical and health care, and safeguard the health of citizens. Article 2 These regulations shall apply to medical institutions such as hospitals, health centers, sanatoriums, outpatient clinics, clinics, health centers (rooms), and first aid stations, etc., which are engaged in the diagnosis and treatment of diseases. Article 3 Medical institutions aim to save lives, prevent and treat diseases, and serve the health of citizens. Article 4 The State supports the development of medical institutions and encourages the establishment of medical institutions in various forms. Article 5 The health administrative department of the state council is responsible for the supervision and management of medical institutions throughout the country.

The administrative departments of health of the local people's governments at or above the county level are responsible for the supervision and management of medical institutions in their respective administrative regions.

The competent health department of the Chinese People's Liberation Army is responsible for the supervision and management of the medical institutions of the army in accordance with these regulations and the relevant provisions of the state. Chapter II Planning Layout and Setup Approval Article 6 The health administrative department of the local people's government at or above the county level shall, in accordance with the population, medical resources, medical needs and the distribution of existing medical institutions in the administrative region, formulate a plan for the setup of medical institutions in the administrative region.

Organs, enterprises and institutions can be set up according to the need for medical institutions, and is included in the local medical institutions set up planning. Article 7 The local people's governments at or above the county level shall incorporate the planning of medical institutions into the local regional health development planning and urban and rural construction and development of the overall plan. Article VIII set up medical institutions should be in line with the medical institutions set up planning and basic standards for medical institutions.

Basic standards for medical institutions developed by the State Council administrative department of health. Article IX units or individuals to set up medical institutions, in accordance with the provisions of the state council shall apply for approval for the establishment of medical institutions, shall be examined and approved by the local people's government at or above the county level of the administrative department of health, and to obtain approval for the establishment of medical institutions. Article 10 Application for the establishment of medical institutions shall submit the following documents:

(1) application for the establishment;

(2) feasibility study report on the establishment;

(3) site selection report and architectural design plan. Article 11 units or individuals to set up medical institutions, shall submit an application for setting up in accordance with the following provisions:

(1) medical institutions without beds or with less than 100 beds, apply to the health administrative department of the people's government at the county level of the place where they are located;

(2) medical institutions with more than 100 beds and specialized hospitals shall apply in accordance with the provisions of the health administrative department of the people's government at the provincial level Article 12 Article XII of the local people's government at or above the county level, the health administrative department shall, within 30 days from the date of acceptance of the application for setting up, to make a written reply of approval or disapproval; approval of the setting up, issued to set up a medical institution approval. Article XIII of the national unified planning for the establishment of medical institutions, the State Council administrative department of health to decide. Chapter III Registration Article XIV medical institutions to practice, must be registered to receive the "medical institutions license"; clinics in accordance with the provisions of the State Council administrative department of health to the local county-level people's government health administrative department for the record, you can practice. Article 15 An application for registration of a medical institution to practice medicine shall have the following conditions:

(1) Where an approval letter for setting up a medical institution should be applied for in accordance with the regulations, an approval letter for setting up a medical institution has been obtained;

(2) It conforms to the basic standards of a medical institution;

(3) It has a suitable name, organization and place;

(4) It has funds, facilities and premises appropriate to the business it carries out;

(4) It has funds, facilities and facilities appropriate to its (d) It has funds, facilities, equipment and professional health technicians appropriate to its business;

(e) It has appropriate rules and regulations;

(f) It is capable of independently assuming civil liability. Article 16 The registration of practice of medical institutions shall be handled by the administrative department of health of the people's government which approves their establishment; the registration of practice of medical institutions which do not need to handle the approval letter for setting up medical institutions shall be handled by the administrative department of health of the local people's government at or above the county level of the place where they are located.

The registration of practice of medical institutions set up in accordance with the provisions of Article 13 of these Regulations shall be handled by the administrative department of health of the people's government of the province, autonomous region or municipality directly under the central government where it is located.

Organs, enterprises and institutions set up for internal staff services clinics, health clinics (rooms), clinic practice registration or filing, by the people's government of the county level health administrative department for the location. Article XVII of the main matters of registration of medical institutions:

(a) name, address, principal person in charge;

(b) form of ownership;

(c) diagnostic and therapeutic subjects, beds;

(d) registered capital. Article 18 The health administrative department of the local people's government at or above the county level within 45 days from the date of acceptance of the application for registration of practice, in accordance with these Regulations and the basic standards of medical institutions for audit. Qualified audit, to be registered, issued "medical institutions license"; audit failed, the results of the audit will be notified in writing to the applicant. Article 19 A medical institution to change its name, place, principal person in charge, diagnostic and therapeutic subjects, beds, must be registered with the original registration authority for change or to the original record-keeping authority for the record. Article 20 of the medical institutions out of business, must be registered with the original registration authority for deregistration or to the original record-keeping organs for the record. Approved by the registration authority, the collection of "medical institutions license".

Medical institutions are not due to alteration, expansion, relocation reasons for more than 1 year out of business, deemed to be out of business.