Applying for an operation license is a mandatory and very important step when establishing and operating a hospital in Vietnam. According to the latest updates, the licensing process has been standardized. The goal is to ensure that medical facilities fully meet professional standards, infrastructure requirements, and legal regulations. This article provides detailed guidance on the procedures, conditions, and current legal framework.

See also the article Vietnam Medical Device Market: A Comprehensive Guide for Foreign Investors

1. Overview of Hospital Operation License

Legal Framework

• Law on Medical Examination and Treatment No. 15/2023/QH15 (effective from January 1, 2024);
• Decree No. 96/2023/ND-CP detailing the implementation of certain provisions of the Law on Medical Examination and Treatment;
• Circular No. 25/2023/TT-BYT on basic technical standards for types of medical examination and treatment facilities;
• Circular No. 32/2023/TT-BYT guiding practice conditions, scopes of practice, and continuous training.

2. Basic Conditions and Requirements

2.1 Infrastructure

Article 41 of Decree 96/2023/ND-CP requires:

• Minimum construction area of 50m²/bed;
• Hospital size:
  • General hospital: minimum 30 beds;
  • Traditional medicine or dental hospital: minimum 20 beds;
  • Specialized hospital > 20 beds; for eye hospital > 10 beds;
• Fully equipped departments: outpatient, inpatient, emergency, laboratory, surgery, sterilization;
• Equipment suitable for the registered professional scope;
• Medical equipment: Must meet conditions in Clauses 3 and 5, Article 40 of Decree 96/2020; Circular 08/2019/TT-BYT on standards and norms for using specialized medical machinery and equipment.
  • The facility must be fully equipped with medical devices appropriate for the registered professional activities.
  • The equipment must have:
    • Clear technical documentation;
    • Regular maintenance, servicing, and inspection;
    • Clear origin and certified quality standards.
• Medical waste treatment system: Hospitals must build treatment systems to meet environmental standards:
  • QCVN 28:2010/BTNMT: National technical regulation on medical wastewater
  • QCVN 07:2009/BTNMT on hazardous waste thresholds
• Accessible architecture: Ensure that persons with disabilities can independently, safely, and conveniently access and use functional areas (QCVN 10:2024/BXD). According to Article 23 and point c, Clause 1, Article 40 of the Law on Persons with Disabilities, medical facilities must renovate and upgrade infrastructure to ensure accessibility for persons with disabilities.
• Fire safety: Must meet TCVN 3890:2023 standards

Learn more about Meeting Medical Equipment Quality Standards in Vietnam

2.2 Medical Personnel

Article 26 of the 2023 Law on Medical Examination and Treatment and Clause 5, Article 41 of Decree 96/2023/ND-CP require:

• Hospital director must have at least a Level I specialty doctor qualification (Article 7, Decision 1289/2024/QD-BYT)
• Must graduate from advanced political theory training, hold a political science degree, or have certification equivalent to advanced political theory.
• Must have held a deputy head or equivalent position for at least 2 years.
• The number of full-time practitioners in each department must exceed 70% of the total practitioners in that department;
• All medical staff must hold valid practice licenses;
• Mandatory continuous training and professional updates (Article 22 of the Law on Medical Examination and Treatment)

3. Hospital Operation Licensing Procedure

Step 1: Prepare Dossier

According to Article 60 of Decree 96/2023/ND-CP, the dossier includes:

• Application form using Form 02 of Appendix II issued with this Decree;
• Valid copies of:
  • Establishment decision or document naming the medical facility
  • Enterprise registration certificate for private medical facilities
  • Investment certificate for foreign-invested medical facilities;
• Copies of practice licenses and confirmation forms using Form 11 of Appendix I of this Decree for:
  • Responsible person
  • Person in charge of the professional department of the medical facility;
• Declaration of infrastructure, list of medical equipment, and personnel meeting licensing requirements;
• List of registered practitioners at the facility;
• Document approved by competent authority:
  • Regulations on functions, duties, and organizational structure of state-owned hospitals
  • Charter of organization and operation for private hospitals
• List of medical techniques provided by the facility;

In case of a first-time application for a license for humanitarian or non-profit medical facilities, financial proof documents are required.

Step 2: Submit Dossier and Appraisal

According to Articles 51 and 52 of the 2023 Law on Medical Examination and Treatment:

• The dossier is submitted to the competent authority as per Article 51;
• Appraisal time is within 60 days from receipt of complete dossier (Clause 4, Article 52).
• If the dossier is incomplete, a written request for completion must be issued within 10 working days from the receipt date. The processing time starts from the date of receiving the completed dossier.
  • If the dossier is complete and valid, the authority will appraise at the facility site to grant the license.
  • If the license is not granted, a written explanation with reasons must be provided.

Refer to the hospital licensing procedure under the Ministry of Health at: Ministry of Health Administrative Procedure Information System

4. Costs and Timelines

Main expenses include:

• Appraisal fee:
  • The fee is set by the Ministry of Finance and collected by the competent authority, depending on hospital scale (Article 4, Circular 59/2023/TT-BTC).
  • The fee varies by type of medical facility.
• Translation, notarization, and consulting fees (if applicable):
  • Applied when the dossier includes foreign language documents or when the investor is a foreign individual/organization.
• Investment in infrastructure, equipment, and personnel:
  • Required to meet licensing conditions (Article 60 of Law No. 15/2023/QH15).
  • Includes cost to build standard hospital, procure proper equipment per technical list, and recruit certified personnel.
• Processing time (Clause 4, Article 52):
  • The competent authority must complete appraisal and licensing within 60 working days from receipt of a valid dossier.
  • Actual time:
    • 2–3 months or longer if documents need amendments or facilities/personnel need improvement.
    • If the dossier is incomplete: a notice must be issued within 10 working days requesting amendment/completion.

5. Important Notes

To ensure a smooth licensing process, pay attention to:

• Stay updated on new regulations to avoid outdated documents.
• Prepare a complete dossier, using correct templates from Decree 96/2023/ND-CP and its appendices.
• Design the hospital according to technical standards, ensuring accessibility (QCVN 10:2024/BXD) and fire safety (TCVN 3890:2023).
• Consult legal and medical experts early to avoid mistakes and shorten licensing time.

6. Frequently Asked Questions

• Is the hospital operation license time-limited?
• The license has no expiration date, but operational conditions are subject to periodic review. (Article 50, Law No. 15/2023/QH15)
• How long does the application process take?
• 60 working days from the date of receiving a valid dossier, possibly longer if amendments are needed. (Article 52, Law No. 15/2023/QH15)
• Can a consultancy firm be authorized to handle the dossier?
• Yes, legal authorization of a qualified consulting unit is allowed to carry out the process. (Articles 138 and 562, Civil Code No. 91/2015/QH13)

Conclusion

Applying for a hospital operation license is a complex process. It requires thorough preparation and strict compliance with regulations. By following the detailed guidance above, medical facilities can more easily complete the licensing procedures.

If you need further advice on the licensing process, please contact your local Department of Health. You can also seek advice from Harley Miller Law Firm experts.

Opportunities for foreign investors: Establishing a Medical Equipment Joint Venture in Vietnam – Strategic Guide for Foreign Partners

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