Introduction

Obtaining a hospital operation license in Vietnam is a mandatory and critical step for any healthcare facility seeking to operate legally. In alignment with national healthcare development strategies and to ensure the quality and safety of medical services, the State has stipulated clear legal requirements, procedures, and licensing processes. This guide provides a detailed and up-to-date overview based on the applicable legal framework as of 2025.

1. Overview of Hospital Licensing 

According to Clause 6 Article 2 and Article 49 of the Law on Medical Examination and Treatment No. 15/2023/QH15 (effective from January 1, 2024), all hospitals operating in Vietnam must obtain an operational license issued by the Department of Health or the Ministry of Health, depending on the type and scale. Licensing is not only a legal requirement but also evidence of the hospital’s compliance with national standards on technical capacity, infrastructure, and organizational structure.

Clause 6, Article 2 defines a medical facility as an entity that has been licensed by a competent authority in Vietnam to provide medical examination and treatment services.

Detailed licensing conditions are also set out in:

• Decree No. 96/2023/ND-CP: Detailing several provisions of the Law on Medical Examination and Treatment;
• Circular No. 25/2023/TT-BYT: Issuing basic technical standards for each type of medical facility.

2. Basic Licensing Conditions

2.1. Infrastructure Requirements (According to Article 41, Decree 96/2023/ND-CP)

• Minimum building scale must correspond to hospital type. For example: General hospitals must have at least 30 beds; the minimum floor area must be 50m²/bed; minimum façade width must be 10 meters.
• Functional departments must include outpatient, inpatient, emergency, surgery, laboratory, sterile area, and administrative-logistics units.
• Departments, rooms, and corridors must be organized in a centralized, continuous, and closed layout ensuring sterile conditions and environmental sanitation.
• Medical solid and liquid waste treatment systems must comply with national standards (TCVN or QCVN).

(According to Articles 105 & 106, Decree 96/2023/ND-CP)

• Medical equipment must be suitable for the hospital’s registered scope of professional activities.
• Facilities must allocate budget for maintenance, calibration, and quality assurance of equipment; and provide ongoing training for staff.
• Equipment must be documented and monitored for use, maintenance, repair, and periodic calibration.

2.2. Human Resources Requirements (According to Article 26 of the 2023 Law on Medical Examination and Treatment; Circular 32/2023/TT-BYT; and Clause 5 Article 41 of Decree 96/2023/ND-CP)

• Medical practitioners must work within the professional scope defined by the Ministry of Health.
• Licensing requires pre-assessment of professional competency for doctors, physician assistants, nurses, midwives, medical technicians, clinical dietitians, paramedics, and clinical psychologists.
• Facilities must meet minimum staffing ratios based on bed count and specialty requirements.
• All healthcare personnel must possess valid practicing licenses as defined in Article 26 of the 2023 Law.
• Circular 32/2023/TT-BYT further outlines conditions on licensing, continuing education, scope of practice, and emergency deployment.

3. Detailed Licensing Procedure

3.1. Dossier Preparation (According to Article 60 of Decree 96/2023/ND-CP)

• Application Form (Form 02, Annex II);
• Certified copies of:
  • Establishment decision for public facilities;
  • Enterprise registration certificate (for private facilities);
  • Investment certificate (for foreign-invested facilities);
• Valid professional licenses and practice verification (Form 11, Annex I) of:
  • Medical director;
  • Head of departments;
• List of infrastructure, medical equipment, and qualified personnel;
• List of practicing personnel (Form 01, Annex II);
• Approval of operational regulations or hospital charter;
• List of medical techniques and services to be provided;
• Financial evidence for humanitarian or non-profit facilities.

3.2. Submission and Appraisal

• Files must be submitted to the competent authority (as per Article 51 of the Law on Medical Examination and Treatment).
• Appraisal deadline: no later than 60 working days from receipt of a valid dossier (Clause 4, Article 52).
• If the dossier is incomplete, the applicant will be notified within 10 working days and asked to supplement the file. The time limit resets upon receipt of a complete dossier.
• For valid applications, the Ministry of Health establishes an appraisal team to inspect the facility and issue a license if compliant.
• If rejected, a written explanation must be provided.

4. Common Challenges and Solutions

4.1. Challenges

• Complex documentation requiring cross-functional coordination (finance, technical, HR…);
• Construction or equipment delays and mismatches;
• Difficulty recruiting licensed healthcare professionals;
• Frequent regulatory updates requiring constant compliance tracking.

4.2. Solutions

• Develop legal-compliant designs from the outset;
• Sign preliminary contracts with equipment providers and HR agencies;
• Use digital tools to monitor licensing timelines and standardize documentation;
• Engage expert consultants throughout the project lifecycle.

5. Frequently Asked Questions (FAQs)

How long does the licensing process take? Usually around 60 working days, not including time to amend and supplement dossiers. In practice, the process may take 3–4 months.

What are the costs of hospital licensing? It varies by hospital scale and type:

• Appraisal fee: According to Circular 59/2023/TT-BTC (pending amendment);
• Costs for consulting, technical dossiers;
• Capital expenditures on construction, equipment, and HR.

6. Conclusion 

The process of obtaining a hospital license in Vietnam is not merely administrative—it reflects the facility’s commitment to quality and compliance. Thorough preparation, legal awareness, and sustainable strategies are key to success. With legal frameworks updated from 2024 onward, investors and healthcare organizations must remain informed and leverage favorable policies to ensure effective and lawful healthcare development.

Note: This guide reflects regulations effective as of 2025. Legal requirements are subject to change. Please consult legal professionals at Harley Miller Law Firm for the most accurate and current advice.

Related Guide: Market Entry for Foreign Investors in Vietnam’s Medical Equipment Sector: Strategic Insights and Licensing Procedures.

Opportunities for Foreign Investors to Form Joint Ventures in Medical Equipment in Vietnam: A Strategic Guide for Foreign Partners

Harley Miller Law Firm

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