LEGAL SERVICES FOR PROCEDURES FOR ESTABLISHING A HOSPITAL (FAST & ALL-INCLUSIVE) 

Under the Law on Medical Examination and Treatment 2023, hospitals are classified as medical examination and treatment establishments subject to strict licensing requirements. This article analyzes in detail the required licensing dossiers, procedures, implementation process, and legal conditions for hospital establishment and operation.

Conditions on Hospital Scale

General hospitals: a minimum of 30 inpatient beds;

Traditional medicine hospitals and dental hospitals: a minimum of 20 inpatient beds;

Specialized hospitals: a minimum of 20 inpatient beds; in particular, ophthalmology hospitals must have at least 10 inpatient beds.

Conditions on Facilities and Infrastructure

Professional departments must be arranged in accordance with their respective functions, ensuring convenience for medical examination and treatment activities;

The hospital must comply with construction requirements prescribed by law, including:

• A minimum gross floor area of 50 square meters per inpatient bed;
• A minimum frontage width of 10 meters, ensuring access for ambulances to the emergency area;
• Examination rooms must meet the minimum area requirements corresponding to outpatient examination rooms as stipulated in Articles 42, 43, 45, 46, Points b and c Clause 1 Article 47, and Article 53 of Decree No. 96/2023/ND-CP;

Where the hospital has professional departments located outside the same campus, there must be traffic infrastructure connectivity among such departments to ensure the safety of patients, patients’ relatives, and medical staff;

The hospital must have a fixed location that complies with legal regulations on structural safety, fire prevention and firefighting, infection control, environmental protection, and radiation safety (if applicable), and must ensure an adequate supply of electricity and water for medical examination and treatment activities;

The hospital must have a signboard and provide layout plans and directional signage to clinical departments, professional units, and administrative sections;

Where additional facilities are established outside the hospital campus, such facilities must meet the specific conditions applicable to each form of medical establishment in accordance with Article 39 of Decree No. 96/2023/ND-CP;

The hospital must be equipped with medical devices suitable for the registered list of professional techniques and scope of professional activities.

Conditions on Organizational Structure and Personnel

Organizational Structure

The hospital must establish the following departments and units:

a) Hospital leadership and management board;

b) Professional departments, including:

– Outpatient department, comprising reception areas, emergency rooms, observation rooms, examination rooms, and rooms for technical procedures and interventions (if applicable);

– Clinical departments:

• For general hospitals: at least 02 out of the following four departments – internal medicine, surgery, obstetrics, and pediatrics;
• For specialized hospitals, traditional medicine hospitals, and dental hospitals: at least one clinical department consistent with the registered scope of professional activities;

– Paraclinical departments: at least one laboratory and one diagnostic imaging unit.

• In the case of ophthalmology hospitals without a diagnostic imaging unit, a professional support contract must be entered into with a licensed medical establishment that has a diagnostic imaging unit;

– Pharmacy department;

– Nutrition department for hospitals with a scale of 100 inpatient beds or more, with at least 01 nutrition professional per 100 beds.

• For hospitals with fewer than 100 beds, a clinical nutrition unit or a designated nutrition officer is required.
• Nutrition personnel must hold a bachelor’s degree in nutrition, or be a licensed physician with at least 06 months of training in clinical nutrition, or a university-level nurse with at least 06 months of training in clinical nutrition;

– Infection control department for hospitals with 150 inpatient beds or more, with at least 01 infection control supervisor per 150 beds.

• For hospitals with fewer than 150 beds, an infection control unit is required.
• Infection control personnel must hold a university degree or higher in a health-related field and possess a certificate, certification, or diploma in infection control;

– Other professional departments must be appropriate to the hospital’s scale, functions, and assigned tasks.

c) Departments or units responsible for general planning, human resources, quality management, nursing, finance and accounting, information technology, medical equipment, and other necessary functions;

d) Depending on facilities and personnel conditions, the head of the medical establishment may decide to establish interdisciplinary departments. The head of such a department must hold a practicing license with a scope of practice consistent with at least one of the relevant specialties.
Where conditions are insufficient to establish a department, specialized units may be established under clinical departments, and the head of such units must hold a practicing license consistent with the unit’s specialty;

e) Operating licenses shall not be issued for institutes or centers established within the hospital campus. Such institutes or centers and their professional units must have professional heads meeting the conditions prescribed in this Decree.

 

Personnel Conditions

The hospital must have a sufficient number of licensed practitioners in accordance with its scale, approved list of professional techniques, and practitioner-to-bed ratios prescribed by the Minister of Health (including practitioners previously licensed by competent authorities within the People’s Armed Forces who no longer serve in such forces but continue to use their valid practicing licenses);

The person in charge of professional and technical activities must be a full-time practitioner of the hospital, with a scope of practice consistent with the hospital’s registered professional activities, and must have at least 36 months of professional practice within such scope, except for traditional medicine practitioners, holders of family remedy formulas, or practitioners of traditional treatment methods;

Where the hospital operates multiple specialties, the practicing license of the person in charge of professional and technical activities must cover at least one of the registered specialties;

Heads of professional departments or units must hold practicing licenses consistent with their specialties and must work full-time at the hospital;

Practitioners must be assigned tasks strictly within the scope of practice approved by competent authorities;

The number of full-time practitioners in each department must account for at least 70% of the total number of practitioners in that department;

Heads of professional departments must be full-time practitioners of the hospital, hold practicing licenses consistent with their specialties, and have at least 36 months of professional practice in such specialties.
Lecturers of healthcare training institutions concurrently working at hospitals serving as training facilities may concurrently hold department head positions;

Heads of other departments not subject to practicing license requirements must hold a university degree relevant to their assigned duties and must work full-time at the hospital;

The hospital must provide inpatient treatment services and organize professional on-duty shifts on a 24/7 basis.

Conditions Applicable to the Company

For a company to be eligible to establish a hospital, the following conditions must be satisfied:

– Business lines: The company must verify whether the hospital operation has been registered as a business line. If not, procedures for supplementation must be carried out, specifically registering business code 8610;

– Hospital location: If the hospital address differs from the company’s head office address, procedures for establishing a dependent business location must be completed at the hospital’s address.

Dossier for Fast, All-Inclusive Hospital Establishment

To establish a hospital under a fast, all-inclusive service package, clients are required to prepare the following documents and provide them to Huy Hoang Law Firm for assistance in obtaining the operating license:

• Application for issuance of an operating license (drafted with support from Huy Hoang Law Firm);
• Declaration of facilities, medical equipment, and personnel (drafted with support from Huy Hoang Law Firm);
• Charter on organization and operation (drafted with support from Huy Hoang Law Firm);
• List of practitioners registering for practice (drafted with support from Huy Hoang Law Firm);
• Proposed scope of professional activities (drafted with support from Huy Hoang Law Firm);
• Enterprise Registration Certificate (for companies) or Household Business Registration Certificate (for household businesses);
• Practicing certificates of the person in charge of professional and technical activities and other personnel;
• Certification of the professional practice process of the person in charge of professional and technical activities;
• Medical waste treatment contract (completed with support from Huy Hoang Law Firm if not yet available);
• Contract for installation of the wastewater treatment system (completed with support from Huy Hoang Law Firm if not yet available).

Note: Under current regulations, when submitting an application for first-time issuance of an operating license, medical establishments are also required to concurrently submit a dossier for approval of the list of professional techniques, including:

• Application for approval of the list of professional techniques;
• Capacity profile;
• Minutes of the professional council meeting;
• Proposed list of professional techniques.

Depending on the specific circumstances of the person in charge of professional and technical activities, the required dossier may vary. We provide tailored consultation for cases such as:

• The responsible physician has retired;
• The physician holds a practicing certificate issued by the Department of Health of another province or city and wishes to establish a hospital in a new locality;
• The physician has not engaged in professional practice continuously for more than two (02) years.

Fast, All-Inclusive Hospital Establishment Services by Huy Hoang Law Firm

By engaging Huy Hoang Law Firm, clients will receive comprehensive legal consultation and all-inclusive support for hospital establishment, including:

• Legal consultation on hospital establishment procedures;
• Assistance in drafting a complete and compliant licensing dossier;
• Guidance on facility preparation and setup to ensure successful appraisal;
• Representation in handling issues arising during the licensing process;
• Assistance in completing medical waste management and wastewater treatment contracts;
• Ongoing legal consultation during hospital operation after licensing, including advertising and approval of professional technique lists.

If you require further information or assistance, please contact Huy Hoang Law Firm for detailed consultation.

The above constitutes an overview of the Fast, All-Inclusive Hospital Establishment Services. Huy Hoang Law Firm hopes this article provides a clearer understanding of the procedures involved and looks forward to supporting you in the future.

Huy Hoang Law Firm

📞 Telephone: +84 944 580 222
📧 Email: tuvan@luathuyhoang.vn
🌐 Website: https://luathuyhoang.vn/
🏢 Address: 2nd Floor, Lot 5, Block 54, Alley 85 Ha Dinh, Khuong Dinh Ward, Hanoi, Hanoi, Vietnam