Implementing Rules for the Administrative Regulations on Medical Institutions
Implementing Rules for the Administrative Regulations on Medical Institutions
Implementing Rules for the Administrative Regulations on Medical Institutions
Order of the Ministry of Health [1994] No.35
August 29, 1994
The Implementing Rules for the Administrative Regulations on Medical Institutions is issued for your implementation.
Chen Minzhang, Minister
Implementing Rules for the Administrative Regulations on Medical Institutions
Chapter I General Provisions
Article 1 These Rules are formulated according to the Administrative Regulations on Medical Institutions (hereinafter referred to as the "Regulations").
Article 2 For the purpose of these Regulations and these Rules, a medical institution shall refer to a registered institution that has obtained the Practitioner's License for Medical Institutions in accordance with the provisions stipulated in the Regulations and these Rules.
Article 3 Medical institutions are divided into the following types,
1. Comprehensive hospitals, traditional Chinese medicine ("TCM") hospitals, TCM and Western medicine integrated hospitals, ethnomedicine hospitals, specialized hospitals and health rehabilitation hospitals;
2. Maternity and child health care hospitals;
3. Central public health centers, health centers at township level, and neighborhood health centers;
4. Sanatoriums;
5. Comprehensive outpatient departments, specialized outpatient departments, outpatient departments of TCM, TCM and Western medicine integrated outpatient departments, and ethnomedicine outpatient departments;
6. Clinics, TCM clinics, ethnomedicine clinics, health clinics, infirmaries, health agencies, and health stations;
7. Village clinics;
8. First-aid centers and first-aid stations;
9. Clinical laboratory centers;
10. Specialized disease prevention and treatment institutes, clinics and stations;
11. Nursing homes and nursing stations; and
12. Other institutions engaging in diagnosis and treatment.
Article 4 Where such an institution as the health and epidemic prevention institution, frontier health and quarantine institution, and medical research and teaching institution intends to carry out diagnosis and treatment activities beyond their own business scope, or a beauty service agency attempts to carry out medical beauty business, it must apply to set up a corresponding type of medical institutions according to the Regulations and these Rules.
Article 5 Medical institutions outside the establishment of the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be administered by local administrative departments of health in accordance with the Regulations and these Rules.
The logistics competent health authority of the People's Liberation Army is responsible for providing local administrative departments of health with the names and addresses of medical institutions outside the establishment of the army.
Article 6 A medical institution that engages in diagnosis and treatment activities according to the law shall be protected by laws.
Article 7 Administrative departments of health shall exercise their powers of supervision and administration independently according to the law, free from any interference by any entity or individual.
Chapter II Examination and Approval of the Setting up
Article 8 All provinces, autonomous regions and municipalities directly under the Central Government shall allocate and utilize medical resources reasonably in accordance with the local plan for setting up medical institutions.
A plan for setting up medical institutions shall be formulated by the local administrative department of health at the county level or above in accordance with the Guiding Principles for the Plan for Setting up Medical Institutions, and be issued for implementation within their respective administrative region after such plan has been examined by the administrative department of health at the next higher level and approved by the people's government at the corresponding level.
The Guiding Opinions for the Plan for Setting up Medical Institutions will be formulated separately.
Article 9 A local administrative department of health at the county level or above shall, according to powers and procedures provided in the Guiding Opinions for the Plan for Setting up Medical Institutions, organize the implementation of the plan for setting up medical institutions for its administrative region, evaluate the implementation regularly, and report the evaluation results to the administrative department of health at the next higher level and the people's government at the corresponding level on an annual basis.
Article 10 Any medical institution, irrespective of its type, form of ownership, subordination, and service targets, shall be set up in conformity with the local plan for setting up medical institutions.
Article 11 For comprehensive hospitals, traditional Chinese medicine ("TCM") hospitals, TCM and Western medicine integrated hospitals, ethnomedicine hospitals, specialized hospitals and health rehabilitation hospitals as well as specialized hospitals, sanatoriums, rehabilitation hospitals, maternity and child health care hospitals, first-aid centers, clinical laboratory centers and specialized disease prevention and treatment institutions which have 100 beds or more, the division of examination and approval powers for setting up the aforesaid institutions shall be stipulated by administrative departments of health of provinces, autonomous regions and municipalities directly under the Central Government, while the setting up of other medical institutions shall be examined and approved by administrative departments of health at the county level or above.
Article 12 In the case of any of the following circumstances, it is prohibited to apply to set up a medical institution,
1. An entity that fails to bear civil liabilities independently;
2. An individual who is serving a term of imprisonment or does not have full capacity for civil conduct;
3. A medical worker who is being employed by a medical institution, has retired due to its illness, or has obtained unpaid leave of absence;
4. A medical worker who has been involved in medical negligence of Grade II or above within the latest five years;
5. A medical worker whose practicing certificate has been revoked due to his/her breach of relevant laws, regulations and rules;
6. The legal representative or principal of a medical institution whose Practitioner's License for Medical Institutions has been revoked; or
7. Other circumstances stipulated by the administrative departments of health of provinces, autonomous regions and municipalities directly under the Central Government.
Any individual that falls under the circumstance of Item 2, Item 3, Item 4, Item 5 or Item 6 listed in the preceding paragraph shall not serve as the legal representative or principal of a medical institution.
Article 13 Any individual that sets up a clinic in a city shall satisfy all the conditions listed as follows,
1. Has passed the practicing technical examination for physicians and gained the practicing certificate of physicians;
2. Has been engaged in clinical practice of a single specialty for five years after obtaining the practicing certificate of physicians or the professional title of physicians; and
3. Other conditions as stipulated by the administrative departments of health of provinces, autonomous regions, and municipalities directly under the Central Government.
The technical standards for physicians' practice will be formulated separately.
Conditions under which an individual may set up a clinic in a town or village shall be stipulated by administrative departments of health of provinces, autonomous regions, and municipalities directly under the Central Government.
Article 14 Where a local people's government at any level plans to set up a medical institution, the setting up application shall be filed by the person who is appointed or nominated by such local government as the head responsible for preparing for the setting up of the scheduled medical institution; where a legal person or other institution plans to set up a medical institution, the said application shall be instituted by its representative; where an individual would like to establish a medical institution, such person shall be responsible for applying; and where two or more persons intend to set up a medical institution in partnership, the application shall go to all partners thereof.
Article 15 The feasibility study report for the setting up required in Article 10 of the Regulations shall include the following information,
1. Name and basic information of the entity filing the application, as well as the name, age, occupational resume and ID number of the applicant;
2. Overview of the population, economic and social development of the area where such entity is located;
3. Health conditions of the people residing in the area where such entity is located, prevalence of disease there as well as the rate of population attacked by certain diseases;
4. Distribution of medical resources in the area where such entity is located and demand analysis of medical services;
5. Name, location, functions, purposes and service radius of the scheduled medical institution;
6. Service mode, service time, medical subjects and number of beds of the scheduled medical institution;
7. Organizational structure and staffing of the scheduled medical institution;
8. Instruments and facilities to be equipped in the scheduled medical institution;
9. The scheduled medical institution's relation with and impacts on other medical institutions within its service radius;
10. Plans of the scheduled medical institution for treating waste water, sewage and feces;
11. Particulars on the scheduled medical institution's communications, power supply, water supply lines, sewer, and fire protection facilities;
12. Capital source, form of investment, aggregate investment, and registered capital;
13. Investment budget for the scheduled medical institution; and
14. Predicted cost-benefit analysis for the scheduled medical institution for five years.
Credit certification of the entity or individual that applies for setting up such institution shall be attached as well.
Where an application is filed for setting up such a medical institution as outpatient department, clinic, health clinic, infirmary, health agency, health station, village clinic, or nursing station, the feasibility study report for the setting up may be simplified to a reasonable extent as the case may be.
Article 16 The report on site selection that shall be submitted as required in Article 10 of the Regulations shall include the following information,
1.
......
Order of the Ministry of Health [1994] No.35
August 29, 1994
The Implementing Rules for the Administrative Regulations on Medical Institutions is issued for your implementation.
Chen Minzhang, Minister
Implementing Rules for the Administrative Regulations on Medical Institutions
Chapter I General Provisions
Article 1 These Rules are formulated according to the Administrative Regulations on Medical Institutions (hereinafter referred to as the "Regulations").
Article 2 For the purpose of these Regulations and these Rules, a medical institution shall refer to a registered institution that has obtained the Practitioner's License for Medical Institutions in accordance with the provisions stipulated in the Regulations and these Rules.
Article 3 Medical institutions are divided into the following types,
1. Comprehensive hospitals, traditional Chinese medicine ("TCM") hospitals, TCM and Western medicine integrated hospitals, ethnomedicine hospitals, specialized hospitals and health rehabilitation hospitals;
2. Maternity and child health care hospitals;
3. Central public health centers, health centers at township level, and neighborhood health centers;
4. Sanatoriums;
5. Comprehensive outpatient departments, specialized outpatient departments, outpatient departments of TCM, TCM and Western medicine integrated outpatient departments, and ethnomedicine outpatient departments;
6. Clinics, TCM clinics, ethnomedicine clinics, health clinics, infirmaries, health agencies, and health stations;
7. Village clinics;
8. First-aid centers and first-aid stations;
9. Clinical laboratory centers;
10. Specialized disease prevention and treatment institutes, clinics and stations;
11. Nursing homes and nursing stations; and
12. Other institutions engaging in diagnosis and treatment.
Article 4 Where such an institution as the health and epidemic prevention institution, frontier health and quarantine institution, and medical research and teaching institution intends to carry out diagnosis and treatment activities beyond their own business scope, or a beauty service agency attempts to carry out medical beauty business, it must apply to set up a corresponding type of medical institutions according to the Regulations and these Rules.
Article 5 Medical institutions outside the establishment of the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be administered by local administrative departments of health in accordance with the Regulations and these Rules.
The logistics competent health authority of the People's Liberation Army is responsible for providing local administrative departments of health with the names and addresses of medical institutions outside the establishment of the army.
Article 6 A medical institution that engages in diagnosis and treatment activities according to the law shall be protected by laws.
Article 7 Administrative departments of health shall exercise their powers of supervision and administration independently according to the law, free from any interference by any entity or individual.
Chapter II Examination and Approval of the Setting up
Article 8 All provinces, autonomous regions and municipalities directly under the Central Government shall allocate and utilize medical resources reasonably in accordance with the local plan for setting up medical institutions.
A plan for setting up medical institutions shall be formulated by the local administrative department of health at the county level or above in accordance with the Guiding Principles for the Plan for Setting up Medical Institutions, and be issued for implementation within their respective administrative region after such plan has been examined by the administrative department of health at the next higher level and approved by the people's government at the corresponding level.
The Guiding Opinions for the Plan for Setting up Medical Institutions will be formulated separately.
Article 9 A local administrative department of health at the county level or above shall, according to powers and procedures provided in the Guiding Opinions for the Plan for Setting up Medical Institutions, organize the implementation of the plan for setting up medical institutions for its administrative region, evaluate the implementation regularly, and report the evaluation results to the administrative department of health at the next higher level and the people's government at the corresponding level on an annual basis.
Article 10 Any medical institution, irrespective of its type, form of ownership, subordination, and service targets, shall be set up in conformity with the local plan for setting up medical institutions.
Article 11 For comprehensive hospitals, traditional Chinese medicine ("TCM") hospitals, TCM and Western medicine integrated hospitals, ethnomedicine hospitals, specialized hospitals and health rehabilitation hospitals as well as specialized hospitals, sanatoriums, rehabilitation hospitals, maternity and child health care hospitals, first-aid centers, clinical laboratory centers and specialized disease prevention and treatment institutions which have 100 beds or more, the division of examination and approval powers for setting up the aforesaid institutions shall be stipulated by administrative departments of health of provinces, autonomous regions and municipalities directly under the Central Government, while the setting up of other medical institutions shall be examined and approved by administrative departments of health at the county level or above.
Article 12 In the case of any of the following circumstances, it is prohibited to apply to set up a medical institution,
1. An entity that fails to bear civil liabilities independently;
2. An individual who is serving a term of imprisonment or does not have full capacity for civil conduct;
3. A medical worker who is being employed by a medical institution, has retired due to its illness, or has obtained unpaid leave of absence;
4. A medical worker who has been involved in medical negligence of Grade II or above within the latest five years;
5. A medical worker whose practicing certificate has been revoked due to his/her breach of relevant laws, regulations and rules;
6. The legal representative or principal of a medical institution whose Practitioner's License for Medical Institutions has been revoked; or
7. Other circumstances stipulated by the administrative departments of health of provinces, autonomous regions and municipalities directly under the Central Government.
Any individual that falls under the circumstance of Item 2, Item 3, Item 4, Item 5 or Item 6 listed in the preceding paragraph shall not serve as the legal representative or principal of a medical institution.
Article 13 Any individual that sets up a clinic in a city shall satisfy all the conditions listed as follows,
1. Has passed the practicing technical examination for physicians and gained the practicing certificate of physicians;
2. Has been engaged in clinical practice of a single specialty for five years after obtaining the practicing certificate of physicians or the professional title of physicians; and
3. Other conditions as stipulated by the administrative departments of health of provinces, autonomous regions, and municipalities directly under the Central Government.
The technical standards for physicians' practice will be formulated separately.
Conditions under which an individual may set up a clinic in a town or village shall be stipulated by administrative departments of health of provinces, autonomous regions, and municipalities directly under the Central Government.
Article 14 Where a local people's government at any level plans to set up a medical institution, the setting up application shall be filed by the person who is appointed or nominated by such local government as the head responsible for preparing for the setting up of the scheduled medical institution; where a legal person or other institution plans to set up a medical institution, the said application shall be instituted by its representative; where an individual would like to establish a medical institution, such person shall be responsible for applying; and where two or more persons intend to set up a medical institution in partnership, the application shall go to all partners thereof.
Article 15 The feasibility study report for the setting up required in Article 10 of the Regulations shall include the following information,
1. Name and basic information of the entity filing the application, as well as the name, age, occupational resume and ID number of the applicant;
2. Overview of the population, economic and social development of the area where such entity is located;
3. Health conditions of the people residing in the area where such entity is located, prevalence of disease there as well as the rate of population attacked by certain diseases;
4. Distribution of medical resources in the area where such entity is located and demand analysis of medical services;
5. Name, location, functions, purposes and service radius of the scheduled medical institution;
6. Service mode, service time, medical subjects and number of beds of the scheduled medical institution;
7. Organizational structure and staffing of the scheduled medical institution;
8. Instruments and facilities to be equipped in the scheduled medical institution;
9. The scheduled medical institution's relation with and impacts on other medical institutions within its service radius;
10. Plans of the scheduled medical institution for treating waste water, sewage and feces;
11. Particulars on the scheduled medical institution's communications, power supply, water supply lines, sewer, and fire protection facilities;
12. Capital source, form of investment, aggregate investment, and registered capital;
13. Investment budget for the scheduled medical institution; and
14. Predicted cost-benefit analysis for the scheduled medical institution for five years.
Credit certification of the entity or individual that applies for setting up such institution shall be attached as well.
Where an application is filed for setting up such a medical institution as outpatient department, clinic, health clinic, infirmary, health agency, health station, village clinic, or nursing station, the feasibility study report for the setting up may be simplified to a reasonable extent as the case may be.
Article 16 The report on site selection that shall be submitted as required in Article 10 of the Regulations shall include the following information,
1.
......