Conditions for establishing a medical examination and treatment company in Vietnam

Medical examination and treatment is one of the essential human needs. Many medical companies were opened. However, to establish companies in this area it is necessary to meet certain conditions. So what are the conditions for establishing a medical examination and treatment company? To answer customers’ questions, Viet An Law Firm offers the article on conditions for establishing a medical examination and treatment company below.

Legal bases

• Schedule of commitments Vietnam in WTO.
• Enterprise Law 2020.
• Law on Medical Examination and Treatment 2023.
• Decree No. 01/2021/ND-CP on business registration.
• Decree 109/2016/ND-CP stipulating the issuance of practice certificates for practitioners and operation licenses for medical examination and treatment establishments, amended and supplemented by Decree 155/2018/ND-CP.

What is medical examination and treatment?

Medical examination is understood as the activity of questioning diseases, exploiting medical history, physical examination, when necessary, prescribing subclinical tests, functional exploration to diagnose and prescribe recognized appropriate treatments.

Healing is the use of recognized professional and technical methods and drugs that have been allowed to be circulated for emergency, treatment, care and rehabilitation for patients.

Thus, the establishment of a medical examination and treatment company is understood as the establishment of a place where tasks such as questioning, medical history exploitation, physical examination are performed, when necessary, prescribing subclinical tests, functional exploration to diagnose and prescribe recognized appropriate treatments; use of the method Technical expertise has been recognized and drugs have been allowed to be circulated for emergency, treatment, care and rehabilitation for patients.

Types of activities of medical examination and treatment company in Vietnam

Pursuant to Clause 3 Article 11 of Decree 155/2018/ND-CP, medical examination and treatment establishments are established in accordance with law and must follow one of the following organizational forms:

• The hospital consists of a general hospital and a specialist hospital.
• The clinic belongs to the People’s Police Force.
• Specialized clinics
• Family medicine examination and treatment establishments (or medical examination and treatment establishments according to family medicine principles): Pilot implementation according to regulations of the Minister of Health.
• Maternity home.
• Medical service facilities

Market access conditions for foreign-invested medical examination and treatment in Vietnam

Vietnam’s commitment to join the WTO

Based on Section 8 of Vietnam’s WTO commitments on health and social services, Vietnam has committed to open the market for foreign investors for hospital services (CPC 9311) and dental and medical examination services (CPC 9312).

Accordingly, to establish a business company of this type, foreign service providers are allowed to provide services through the establishment of a 100% foreign-invested hospital, a joint venture with a Vietnamese partner or through a business cooperation contract.

The minimum investment for a hospital is US$20 million, a policlinic is US$2 million, and a specialty treatment facility is US$200,000.

Conditions for establishing a medical examination and treatment company in Vietnam

Article 23a of Decree 109/2016/ND-CP amended and supplemented by Decree 155/2018/ND-CP stipulates general conditions for granting licenses for operation of medical examination establishments as follows:

Scale conditions

The first thing to establish a medical examination and treatment company is to meet the conditions on the legal scale as prescribed. Pursuant  to Article 23 on conditions for granting operation licenses to hospitals in Decree 109/2016/ND-CP, the size of the hospital is determined according to the criteria of the number of beds and equipment, specifically as follows:

• For hospitals: General hospitals must have at least 30 beds; Specialized hospitals and traditional medicine hospitals must have at least 20 beds; Particularly, ophthalmic and psychiatric hospitals must have at least 10 beds.
• For polyclinics: There must be at least 02 out of 04 specialties of internal medicine, surgery, obstetrics and pediatrics; There is a subclinical department (laboratory and diagnostic imaging).
• For specialized clinics and medical service establishments: Specialized clinics must have medical examination and treatment rooms with an area of at least 10 m2 and places to receive patients (except for health consulting clinics or health consulting rooms through information technology means, telecommunications).

In addition, depending on the scope of specific professional activities, specialized clinics and medical service establishments will have to meet the size of other areas as prescribed.

Facilities conditions

Conditions on facilities that all medical clinics must meet include:

• Having a fixed location (except for the case of organizing mobile medical examination and treatment);
• Ensure conditions on radiation safety and fire prevention and fighting in accordance with the provisions of law;
• A sterilization area must be arranged for the handling of reusable medical instruments, except in cases where there are no instruments to be re-sterilized or there is a contract with another medical facility to sterilize instruments.

In addition, depending on the scale and scope of specific professional activities, each type of clinic, hospital and medical service facility will have to meet other specific facilities conditions as prescribed for each type.

Conditions on medical equipment

In addition to conditions on scale and facilities, medical examination and treatment companies must meet conditions on medical equipment, including:

• For hospitals: there must be sufficient emergency transport in and out of the hospital. In case there are no emergency facilities outside the hospital, a contract must be signed with a medical examination and treatment establishment that has been licensed to operate and has the scope of professional activities in providing emergency services to assist in transporting patients.
• For clinics and medical service establishments: Having sufficient medical equipment suitable to the scope of professional activities of the establishment;

In addition, depending on the type of activity and scope of professional activities, clinics and health service facilities must meet other conditions such as:

• Particularly, occupational disease examination and treatment establishments must have at least biochemical testing departments;
• Health consultancy clinics or health consulting rooms through information technology and telecommunications means are not required to have appropriate medical equipment, biochemical testing departments but must have sufficient information technology, telecommunications and equipment suitable to the scope of registration activities…

Personnel conditions

Medical examination and treatment companies need to meet the following personnel conditions:

• All personnel practicing at medical examination and treatment establishments must have practicing certificates suitable to the scope of professional activities registered for practice and the scope of technical expertise of medical examination and treatment establishments.
• Practitioners at State medical examination and treatment establishments may not register as heads of private hospitals or medical examination and treatment establishments established and operating under the Law on enterprises and the Law on cooperatives, unless they are appointed by competent state agencies to participate in management, operate at medical examination and treatment establishments with state capital.
• Each medical examination and treatment facility must have 1 person responsible for technical expertise; Persons in charge of technical expertise and heads of specialized departments of medical examination and treatment establishments must also meet the requirements of practicing certificates, organic practitioners at establishments and have practiced medical examination and treatment for at least 36 years.

For hospitals, the following additional conditions must be met:

• The number of full-time (permanent) practitioners in each department must be at least 50% of the total number of practitioners in the department;
• Heads of specialized departments of hospitals must have practicing certificates appropriate to that specialty and must be an organic practitioner at the hospital;
• Other deans who are not subject to practising certificates must have a university diploma with a major suitable to the assigned job and must be an organic practitioner at the hospital.

Having a dossier of application for an establishment and operation license according to regulations

A dossier of application for an operation license for a medical examination and treatment establishment is specified in Decree 109/2016/ND-CP, including:

• An application for an operation license according to Form 01 of Appendix XI enclosed;
• A valid copy of the establishment decision or a document bearing the name of the medical examination and treatment establishment of a competent state agency for the State’s medical examination and treatment establishment or an enterprise registration certificate for a private medical examination and treatment establishment or an investment certificate for a medical examination establishment, foreign-invested medical treatment;
• A valid copy of the practicing certificate of the person responsible for professional and technical expertise of the medical examination and treatment establishment; persons in charge of specialized departments of medical examination and treatment establishments;
• List of registration of practitioners at medical examination and treatment establishments (including registration of practitioners and persons working in medical professions at establishments but not subject to issuance of practice certificates) according to the form specified in Appendix IV enclosed;
• Declaration of facilities, medical equipment, organization and personnel of medical examination and treatment establishments according to Form 02 of Appendix XI enclosed;
• Documents proving that medical examination and treatment establishments satisfy conditions on material foundations, medical equipment and personnel organization in accordance with the scope of professional activities of one of the organizational forms specified in Section 1, Chapter III of the Decree;
• A valid copy of the contract for the carriage of the patient for a maternity home that does not have an off-site emergency transport;
• The list of technical expertise of medical examination and treatment establishments shall be proposed on the basis of the list of technical expertise promulgated by the Director of provincial-level Health Services;
• Expected scope of professional activities: Medical examination and treatment establishments shall propose the scope of professional activities and the proposed technical list on the basis of the list of professional techniques promulgated by the Director of provincial-level Health Services.

If you want to establish a medical examination and treatment company, please contact Viet An Law Firm for the best support!