[2025 Update] Procedures for the Establishment of a Foreign-Invested Hospital in Vietnam (CPC 9311)

I. Legal Basis:

- Specific Commitments on Trade in Services under the WTO's General Agreement on Trade in Services (GATS);

- Law on Investment No. 61/2020/QH14 dated June 17, 2020;

- Law on Enterprises No. 59/2020/QH14 dated June 17, 2020;

- Law on Medical Examination and Treatment No. 15/2023/QH15 dated January 9, 2023;

- Decree No. 96/2023/ND-CP dated December 30, 2023, detailing the Law on Medical Examination and Treatment.

II. General Conditions for Licensing Medical Examination and Treatment Facilities

1. Scale: Possess a scale appropriate for each organizational form of the medical examination and treatment facility.

2. Physical Facilities:

a) Have a fixed location that meets the legal regulations on: load-bearing safety, fire prevention and fighting, infection control, environmental protection, radiation safety (if applicable); ensure sufficient electricity and water supply for the facility's operations.

b) Have a signboard, a layout map, and directional signs to departments, specialized and administrative divisions.

c) In cases where there are additional facilities not within the premises of the medical examination and treatment facility, the specific conditions for each organizational form of the medical examination and treatment facility as stipulated in Article 39 of this Decree must be met.

3. Have medical equipment appropriate for the registered technical professional list and scope of operation.

4. Personnel:

a) Have sufficient practitioners according to the scale and technical list, and meet the practitioner ratio prescribed by the Minister of Health (including practitioners licensed by competent authorities of the people's armed forces who no longer work in the people's armed forces but continue to use their issued practice certificates).

b) The person responsible for professional and technical matters must be a full-time practitioner of the facility, have a scope of practice suitable for the facility's professional activities, and have practiced in that scope for at least 36 months, except for practitioners holding the title of traditional medicine doctor (lương y), those with traditional remedies, or those with traditional healing methods. In cases where the medical examination and treatment facility has multiple specialties, the practice certificate of the person responsible for professional and technical matters must have a scope of practice suitable for one of the specialties for which the facility registers its operation.

c) Heads of professional departments and units of the facility must have a practice certificate appropriate to that specialty and must be full-time practitioners at the facility. d) Practitioners must be assigned work within the scope of practice approved by competent authorities.

dd) Medical technicians with a bachelor's degree and a scope of practice in medical laboratory testing are entitled to read and sign test results. In cases where the medical examination and treatment facility does not have a practitioner licensed with the title of specialist doctor in medical laboratory or a medical technician with a bachelor's degree and a scope of practice in medical laboratory testing, the requesting doctor shall read and sign the test results.

e) Medical technicians with a bachelor's degree and a scope of practice in medical imaging are entitled to read and describe diagnostic images. In cases where the medical examination and treatment facility does not have a practitioner licensed with the title of specialist doctor in medical imaging or a medical technician with a bachelor's degree and a scope of practice in medical imaging, the requesting doctor for diagnostic imaging shall read and sign the diagnostic imaging results.

g) Other individuals involved in the medical examination and treatment process who are not required to have a practice certificate as stipulated in Point d, Clause 2, Article 19 of the Law on Medical Examination and Treatment (medical physicists, radiotherapy engineers, biotechnology engineers, biotechnology graduates, and others, hereinafter referred to as "workers") are allowed to perform professional activities as assigned by the person responsible for professional and technical matters of the medical examination and treatment facility. The assignment must be appropriate to their professional qualifications and capabilities.

h) In cases where a practitioner is a lecturer at a health science training institution and simultaneously works at a medical examination and treatment facility that is a practice facility of that training institution, they may concurrently hold leadership positions in the professional departments of the medical examination and treatment facility.

5. Facilities organizing health check-up activities, in addition to being organized as a hospital or a polyclinic, must also meet the following conditions: a) Have sufficient clinical, paraclinical departments, personnel, and necessary medical equipment to examine and detect health conditions according to the health standards and health check-up form issued with the health check-up guidelines. b) Ensure data connectivity of driver's health examination certificates with the Information System for Management of Medical Examination and Treatment Activities or the national health database or the data receiving portal of the Health Insurance Assessment Information System.

6. Facilities organizing HIV/AIDS examination and treatment activities, in addition to being organized as a hospital or clinic, must also meet the following conditions: a) Physical facilities: have a minimum area of 18m² (excluding the waiting area), divided into two rooms for medical examination and patient counseling. b) Personnel: the person responsible for professional and technical matters of the HIV/AIDS examination and treatment clinic must be a practitioner with the professional title of doctor and have a certificate of training in HIV/AIDS examination and treatment issued by a legitimate training institution. c) Have an anaphylaxis emergency kit and sufficient specialized emergency medications appropriate to the specialties within the professional scope of the clinic.

7. Facilities organizing medical examination and treatment for occupational diseases, in addition to being organized as a hospital, polyclinic, interdisciplinary clinic, specialized clinic, or general practitioner clinic, must also meet the following conditions:

a) Be able to perform biochemical tests appropriate to the occupational disease diagnosis guidelines that the facility plans to implement.

b) Have medical equipment appropriate to the technical professional list and the list of occupational diseases registered for examination and treatment.

c) Individuals performing medical examination and treatment for occupational diseases must have a practice certificate with the title of doctor with a scope of medical practice and a certificate of training in occupational diseases, or a doctor with a scope of preventive medicine practice and a certificate of training in occupational diseases.

d) In cases of independent facilities solely providing medical examination and treatment for occupational diseases, the person responsible for professional and technical matters of the facility must meet the following conditions:

- Be a doctor with a practice certificate in occupational diseases, or a doctor with a practice certificate in a specialized field and a certificate of training in occupational diseases, or a doctor with a practice certificate in medical practice and a certificate of training in occupational diseases.

- Have at least 36 months of practice in medical examination and treatment after being granted a practice certificate or license.

8. Medical examination and treatment facilities organizing HIV/AIDS testing activities, in addition to being organized as a hospital, polyclinic, interdisciplinary clinic, specialized clinic, general practitioner clinic, or paraclinical service facility, must also meet the conditions stipulated in Decree No. 75/2016/ND-CP dated July 1, 2016, of the Government on the conditions for HIV testing.

9. Medical examination and treatment facilities organizing in vitro fertilization and surrogacy for humanitarian purposes, in addition to being organized as a hospital, must also meet the conditions stipulated in Decree No. 10/2015/ND-CP dated January 28, 2015, of the Government on in vitro fertilization and the conditions for surrogacy for humanitarian purposes.

10. Medical examination and treatment facilities specified in Clauses 1, 2, 3, 4, and 7 of Article 39 of this Decree are allowed to provide examination, consultation, and preventive treatment services.

11. Medical examination and treatment facilities that have been licensed to operate under one of the forms specified in Article 39 of this Decree are allowed to provide services of other organizational forms or provide health check-up services, medical examination and treatment for HIV/AIDS or occupational diseases if they meet the conditions of that organizational form. In cases where the conditions for providing services of other organizational forms are met, or the conditions for providing health check-up services, examination, and treatment of HIV/AIDS are met at the time of requesting a new operating license, a request for appraisal of those services may be submitted concurrently with the appraisal for the operating license. In cases where the conditions are met after the operating license has been granted, the procedures for adjusting the operating license shall be followed. However, for the provision of health check-up services, examination, and treatment of HIV/AIDS, it is not necessary to adjust the operating license, but a declaration procedure must be carried out as stipulated in Article 69 of this Decree. In cases where medical examination and treatment services are provided according to the principles of family medicine, there must be a practitioner with the title of doctor who meets one of the following conditions:

- Have a scope of practice in family medicine.

- Have a certificate of training in family medicine for at least 03 months.

- Have a certificate of attending courses with content recorded in a confirmation or credit certificate or a family medicine training program with a total duration of at least 03 months.

12. Facilities providing the following cosmetic services or using products with pharmacological effects must be established in one of the following organizational forms: hospital, polyclinic, or specialized clinic: a) Cosmetic services using drugs, substances, and equipment to intervene in the human body (surgery, procedures, interventions involving injections, infusions, pumping, irradiation, waves, burning, or other invasive interventions) for the purpose of:

- Changing skin color, shape, increasing weight, reducing weight (weight loss, body fat reduction).

- Correcting defects or shaping according to desire for parts of the body (skin, nose, eyes, lips, face, chest, abdomen, buttocks, and other parts of the human body).

- Regenerating or restoring cells, organs, or bodily functions. b) Tattooing, spraying, and embroidery on the skin using injectable anesthetics.

13. In cases where the medical examination and treatment facility is a charitable facility or a non-profit medical examination and treatment facility, in addition to meeting the conditions stipulated from Clauses 1 to 12 of this Article, the following conditions must also be met: a) Other specific conditions corresponding to the organizational form of the charitable or non-profit medical examination and treatment facility. b) Have financial resources for charitable medical examination and treatment activities. c) The signboard of the medical examination and treatment facility must clearly state that it is a charitable or non-profit medical examination and treatment facility.

III. Conditions for Licensing Hospitals

In addition to meeting the general conditions stipulated in Article 40 of this Decree, hospitals must also meet the following conditions:

1. Hospital Scale:

a) General hospital: minimum of 30 beds;

b) Traditional medicine hospital, dental and maxillofacial hospital: minimum of 20 beds;

c) Specialized hospital: minimum of 20 beds; specifically for ophthalmology hospitals: minimum of 10 beds.

2. Physical Facilities:

a) Arrange specialized departments appropriately to the function of each department, convenient for medical examination and treatment.

b) Meet the construction requirements according to the law, including: ensuring a minimum construction floor area of 50 m²/bed; the width of the hospital's front (façade) must be at least 10 m, ensuring access for ambulances to and from the emergency area; examination rooms within the hospital must meet the minimum area requirements equivalent to the corresponding examination rooms specified in Articles 42, 43, 45, 46, Point b, c Clause 1 Article 47, and Article 53 of this Decree.

c) In cases where the hospital has specialized departments not located within the same premises, there must be transportation infrastructure connecting the departments to ensure the safety of patients, their families, and medical staff.

3. Transportation: Have ambulance vehicles for in-hospital and out-of-hospital emergency transport. If there are no out-of-hospital emergency transport vehicles, there must be a contract with a local facility capable of providing emergency services and patient transport support.

4. Organization:

a) Hospital leadership and management board.

b) Specialized departments: Hospitals are organized into specialized departments for examination, clinical, paraclinical, pharmacy, and support services, including:

- Examination department: with a reception area, emergency room, observation room, examination rooms, and procedure rooms (if performing techniques and procedures).

- Clinical department: have at least two of the four departments: internal medicine, surgery, obstetrics, pediatrics for general hospitals, or one clinical department appropriate to the professional scope of operation for specialized hospitals, traditional medicine hospitals, and dental and maxillofacial hospitals.

- Paraclinical department: have at least one laboratory and one diagnostic imaging room. Specifically, ophthalmology hospitals, if they do not have a diagnostic imaging department, must have a professional support contract with a licensed medical examination and treatment facility that has a diagnostic imaging department.

- Pharmacy department.

- Nutrition department for hospitals with a scale of 100 beds or more; for every 100 beds, there must be at least 01 person specializing in nutrition. A clinical nutrition unit or a person in charge of nutrition for hospitals with a scale of fewer than 100 beds; nutritionists must be nutrition graduates or practitioners with the title of doctor with a clinical nutrition training certificate of 06 months or more, or university-level nurses with a clinical nutrition training certificate of 06 months or more.

- Infection control department for hospitals with a scale of 150 beds or more; for every 150 beds, there must be at least 01 infection control surveillance staff. An infection control unit for hospitals with a scale of fewer than 150 beds; infection control staff must have a university degree or higher in health sciences and have a certificate or diploma in infection control.

- Other specialized departments in the hospital must be appropriate to the scale and functions.

c) Have rooms and departments to perform functions related to general planning, personnel organization, quality management, nursing, finance and accounting, information technology, medical equipment, and other necessary functions.

d) Depending on the physical facilities and human resources, the head of the medical examination and treatment facility decides on the establishment of specialized departments in the form of interdisciplinary departments; the professional head of this department must have a practice certificate with a scope of practice suitable for at least one of the specialties. If the conditions for establishing a department are not met, a unit under the clinical departments may be established; the head of this unit must have a practice certificate with a scope of practice suitable for the specialty of that unit.

dd) Operating licenses are not granted to specialized departments that are institutes or centers directly under and within the premises of the hospital; these institutes, centers, and their specialized units must have a professional head who meets the conditions stipulated in this Decree.

5. Personnel:

a) The number of full-time practitioners in each department must reach a minimum of 70% of the total number of practitioners in the department.

b) Heads of specialized departments of the hospital must be full-time practitioners of the hospital and have a practice certificate appropriate to the specialty of the assigned professional department, with at least 36 months of practice in that specialty. In cases where a practitioner is a lecturer at a health science training institution and simultaneously works at a medical examination and treatment facility that is a practice facility of that training institution, they may concurrently hold the head position of a department at the medical examination and treatment facility.

c) Heads of other professional departments not subject to practice certificate issuance must have a university degree in a major appropriate to their assigned work and must be full-time employees of the hospital.

6. Hospitals must provide inpatient treatment and organize 24/24-hour professional on-call duty for all days.

IV. Capital Requirements:

According to the Specific Commitments on Trade in Services under the WTO's General Agreement on Trade in Services (GATS), the minimum investment capital for a hospital is 20 million US dollars, while for a polyclinic, the minimum investment capital is stipulated at 2 million US dollars. Meanwhile, specialized treatment facilities, focusing on one or a few specific medical fields, have a lower minimum investment capital, at 200 thousand US dollars. Fully meeting the capital requirements is not only a legal obligation but also a solid foundation for the sustainable development and reputation of the healthcare facility in the future.

 

The information contained in this article is general and intended only to provide information on legal regulations. DB Legal will not be responsible for any use or application of this information for any business purpose. For in-depth advice on specific cases, please contact us.

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