1. Current Legal Framework

Medical examination and treatment is a conditional business sector, requiring participating organizations and individuals to strictly comply with the technical and legal standard systems promulgated by state management agencies. Applying for an operation license for a private clinic requires the enterprise and facility owner to establish absolute consistency among administrative documents, personnel capacity, physical infrastructure, and the scope of professional activities.   

As of June 2026, the legal framework governing the licensing procedures for medical examination and treatment facilities includes the Law on Medical Examination and Treatment No. 15/2023/QH15, Decree No. 96/2023/ND-CP, and Circular No. 32/2023/TT-BYT. Most recently, the Government issued Resolution No. 21/2026/NQ-CP and the Ministry of Health issued Circular No. 02/2026/TT-BYT to simplify administrative procedures and decentralize resolution authority.   

Resolution No. 21/2026/NQ-CP abolishes 298 business conditions in the healthcare sector, shifting the state management methodology toward a focus on empirical on-site assessment. Circular No. 02/2026/TT-BYT stipulates the decentralization of the complete authority to receive dossiers, organize appraisal teams, and issue or adjust operation licenses for private medical facilities to the Departments of Health of provinces and centrally run cities. This transition mandates that enterprises elevate their accountability and prepare comprehensive actual evidence documents archived on-site to facilitate specialized inspection and examination activities.   

2. Classification of Organizational Forms and Standard Conditions

The prerequisite step in the dossier preparation process is accurately identifying the organizational form of the medical examination and treatment facility pursuant to Article 39 of Decree No. 96/2023/ND-CP. Each form entails specific standards regarding organizational structure, minimum area, and technical catalogs. The following are the common organizational forms and standard conditions:   

• General Clinics: Pursuant to Article 42 of Decree No. 96/2023/ND-CP, a general clinic must encompass at least three specialties, mandatorily including at least two of the four core specialties: internal medicine, surgery, obstetrics, and pediatrics. The facility is required to establish a paraclinical department comprising a laboratory and a diagnostic imaging room, while also arranging an emergency room, a minor surgery room for cases involving procedures, and a patient retention room.   
• Specialized Clinics: Pursuant to Article 43 of Decree No. 96/2023/ND-CP, specialized clinics must arrange a patient reception area and a medical examination room with a minimum area of 10 square meters. In the event of performing procedures, the enterprise must design additional corresponding functional rooms, meeting infection control standards stipulated by the Ministry of Health.   
• Clinics Providing Aesthetic Services: According to Clause 12, Article 40 of Decree No. 96/2023/ND-CP, facilities providing aesthetic services utilizing drugs or devices that intervene in the human body must be established in the form of a hospital or specialized clinic and strictly comply with infection control regulations.   
• Paraclinical Service Facilities: Comprising laboratories and diagnostic imaging facilities, which must meet rigorous standards for radiation safety and biosafety.   

Based on the roadmap for standardizing human resource quality in the 2023 Law on Medical Examination and Treatment, state agencies will cease issuing practice licenses for the title of intermediate-level medical assistant after December 31, 2026. Aligned with this legal regulation, by mid-2026, the People’s Committees and Departments of Health of provinces and cities have issued official decisions abolishing administrative procedures related to the issuance of new operation licenses for the general medical assistant clinic form. Consequently, this organizational form is no longer applicable for new establishment registrations nationwide.   

3. Three Core Condition Groups in the Licensing Dossier

The licensing dossier necessitates uniformity and synchronization among three fundamental condition groups.Information discrepancies among these document groups constitute the primary reason for management agencies to issue documents refusing licensure. The core condition groups include:   

• Condition Group Regarding Physical Infrastructure and Functional Zoning: The enterprise must provide detailed floor plan blueprints, explicitly annotating the function and area of each room to ensure compliance with current minimum regulatory thresholds. The floor plan design must adhere to the principle of one-way movement, clearly segregating movement flows for clean and contaminated zones to meet infection control standards, particularly applicable to procedure areas and medical instrument processing zones.   
• Condition Group Regarding Personnel Capacity and Practice Licenses: All personnel participating in medical examination and treatment activities must mandatorily possess a practice license with a professional scope appropriate for their assigned work position. The chief medical officer must be an individual practicing full-time at the facility, meeting the condition of continuous practice seniority of a minimum of 36 months for specialized clinics or 54 months for general clinics. The enterprise is responsible for providing valid documentation proving labor relations, including labor contracts and specific task assignment decisions.   
• Condition Group Regarding Professional Scope and Technical Catalog: The proposed technical service catalog must be established based on the professional technical catalog issued by the Ministry of Health, and must simultaneously be compatible with the personnel capacity and medical equipment systems currently available at the facility. Proposing the approval of a technical catalog that exceeds the actual capacity of the equipment or exceeds the scope of the personnel’s practice licenses will result in an unsatisfactory dossier outcome.   

4. Comprehensive Checklist of Dossier Components

Pursuant to Article 60 of Decree No. 96/2023/ND-CP, the application dossier for a new operation license for a medical examination and treatment facility encompasses detailed components systematized in the checklist below. Medical facilities should utilize this checklist to verify document validity prior to official submission.  This is checklist for preparing documents.

5. Establishing the Practical Evidence Portfolio for Field Appraisals

Finalizing the administrative document dossier is the initial step in the licensing process. To meet the standards of the empirical assessment management methodology, enterprises bear the responsibility of establishing and archiving a current-state evidence portfolio at the facility for presentation immediately upon inspection by the appraisal team. The evidence portfolios include:   

• Evidence Documents Regarding Personnel: Internal records must demonstrate compliance with labor laws and operational reality. This document system includes detailed shift assignment boards posted in departments, actual timesheets for personnel who have commenced work, professional task assignment decisions with confirmation signatures from relevant parties, and minutes from periodic professional meetings attended by the medical staff.   
• Evidence Documents Regarding Physical Infrastructure: The enterprise must establish a system archiving current-state images of each functional area. Photographic documentation must clearly display spatial area, ventilation systems, fire protection equipment, surgical scrub sinks, and the installation location of specialized medical equipment. Accompanying this, the facility drafts a functional cross-reference document, specifically identifying which room area is responsible for accommodating the execution of the corresponding specialized technical catalog group.   
• Evidence Documents Regarding Medical Equipment: The medical equipment management record system archived at the facility includes the equipment’s operational logbook, handover and acceptance minutes from the supplier, value-added tax invoices, and legal medical device circulation certificates. For machinery emitting radiation or specialized metrology equipment, the facility is mandatorily required to archive periodic safety inspection and technical calibration minutes executed by state-licensed metrology organizations.   

6. Identification of Common Administrative Violations and Remedial Strategies

The activity of reviewing internal dossiers to detect and adjust invalid points is a mandatory procedure to minimize the regulatory agency issuing documents demanding dossier revisions multiple times. Common administrative violations and remedial strategies include:   

• Personnel Failing to Meet Professional Conditions: Violations concerning personnel failing to meet professional conditions occur when a facility registers to request approval for a professional technical catalog, yet the responsible personnel do not possess a practice license with the corresponding scope, or the dossier lacks labor contracts proving the working relationship. The remedial strategy requires the enterprise to proceed with narrowing the requested technical catalog to align with current personnel, or execute the supplementary recruitment of personnel meeting legal conditions. The standard preventative measure is establishing a cross-reference matrix between each registered technical service and the responsible personnel’s practice scope.   
• Floor Plans Violating Medical Design Standards: Violations related to floor plans non-compliant with medical design standards arise when blueprints omit mandatory functional rooms, or fail to delineate clean and contaminated movement flows, resulting in a conclusion of failing infection control standards. The remedial strategy requires the enterprise to redesign the floor plan blueprints reflecting accurate actual dimensional proportions, strictly adhering to the one-way flow principle and infrastructure design standards applied by the Ministry of Health for each specific medical facility model.   
• Registering Technical Catalogs Incompatible with Actual Conditions: The situation of registering technical catalogs incompatible with actual conditions frequently occurs when facilities register technical services requiring complex sterile systems or specialized equipment at a time when the machinery has not been completely installed. The resolution strategy is to draft the technical list based on the functionality of the equipment and personnel present at the time of dossier submission, applying a phased investment strategy where technical catalog supplementation is executed in a subsequent phase.   
• Medical Equipment Lacking Origin Documentation: The error of declaring medical equipment lacking origin documentation is formed by including practically unpurchased equipment in the declaration list, or lacking invoices and quality inspection minutes for the group of used equipment. Enterprises must proceed to remove equipment not present at the facility from the declaration list, while simultaneously collecting and supplementing comprehensive documentation proving legal ownership and safety calibration minutes for operating equipment.   
• Inconsistent Administrative Information: Violations concerning inconsistent administrative information manifest through character discrepancies regarding the clinic name, address, or personnel titles across the application form, lease contract, and practice licenses. To rectify this, the enterprise must establish a standard information data system as a master base, while executing a synchronized cross-review procedure across the entire document form system prior to the legal representative proceeding to sign and stamp.   
• Lease Contracts Lacking Legal Clauses: Location lease contracts lacking a long duration or a clause determining the purpose of use as a medical facility invalidates the dossier. The enterprise must request the property owner to sign a contract appendix supplementing appropriate clauses before notarization.   
• Dossiers Lacking Quality Management Procedures: Failing to issue sufficient quality management procedures or using procedures unsuitable for the facility’s specifics leads to an unsatisfactory dossier. The facility must issue operating procedures approved and signed by the chief medical officer before submission.   
• Chief Medical Officer Lacking Sufficient Seniority: Pursuant to Decree No. 96/2023/ND-CP, personnel in charge of professional matters not meeting the minimum 36 months of valid practice will not be approved. The enterprise must change the person in charge or adjust the clinic’s operating scope to match the current personnel’s seniority.   
• Invalid Certified Copies of Documents: Document copies that are dog-eared, illegible, or have an expired certification seal are rejected at the receiving counter. The enterprise must obtain new certified copies from competent state agencies.   
• Facilities Incomplete at the Time of Appraisal: Submitting an appraisal application when the facility is under construction or equipment systems are incomplete leads to a failed appraisal result. The facility must organize a review of all items according to the health agency’s inspection checklist before the appraisal team’s working day.   

7. Execution Sequence, Procedures, and Resolution Fees

The appraisal and operation licensing process for medical examination and treatment facilities complies with administrative procedures prescribed by the Government and the Ministry of Health. Pursuant to Circular No. 02/2026/TT-BYT, the provincial People’s Committees and Departments of Health of provinces and centrally run cities are the competent authorities to receive dossiers, organize appraisals, and issue new, reissue, or adjust operation licenses for private medical facilities operating within their jurisdiction.   

The standard resolution sequence encompasses the following steps:

1. Dossier and Fee Submission: The enterprise submits the administrative dossier along with the attached document system at the receiving and result-returning department of the local Department of Health, or submits online via the National Public Service Portal, simultaneously paying the appraisal fee. The appraisal fee rate for issuing a new operation license applicable to specialized clinics, inter-specialty clinics, medical doctor clinics, odonto-stomatology clinics, nutrition clinics, and paraclinical service facilities is 4,300,000 VND per dossier. For the form of traditional medicine clinics, traditional medicine diagnosis and treatment rooms, and medical stations, the appraisal fee rate is prescribed at 3,100,000 VND per dossier.   
2. Reception and Validity Review: The management agency inspects the legality and synchronization of the document system, issuing a specific notification document demanding supplements or adjustments if requirements are not met.   
3. On-site Field Appraisal: Once the paper dossier is confirmed valid, the state agency issues a decision establishing a field appraisal team to inspect, cross-referencing declared information with the actual state of physical infrastructure capacity, medical equipment system operational capability, and personnel records archived at the clinic.   
4. Issuance of Operation License: Based on a satisfactory appraisal minute, the Department of Health issues the Decision granting the Medical Examination and Treatment Operation License to the facility.   

To accelerate administrative resolution, enterprises must implement the following optimization strategies:

• Standardize the checklist system from Day 1: Avoid preparing dossiers in a piecemeal, directionless manner.   
• “Adequate Scope” Strategy: Do not register excess specialized services when lacking actual operational capacity at the facility to minimize supplemental explanations.   
• 100% Transparent Personnel Dossiers: Ensure all labor contracts and professional shift schedules are complete, original, and ready for immediate presentation.   
• Proactively Organize an Internal Pre-audit: The management team must walk the facility with the checklist, acting as inspectors to verify flows, equipment readiness, and signage before the appraisal day.   
• Apply Version Control Mechanisms: Assign a single focal point personnel responsible for updating dossiers, ensuring the archived version perfectly matches the version submitted to the Department of Health.   

8. Conclusion

The task of compiling a dossier to request a private clinic operation license in Vietnam requires organizations and individuals to firmly grasp the legal regulatory system and execute administrative risk management stringently. Under the orientation of shifting the management methodology to a focus on empirical inspection pursuant to the regulations in Resolution No. 21/2026/NQ-CP and Circular No. 02/2026/TT-BYT, ensuring absolute synchronization among infrastructure capacity, legal personnel dossiers, and professional operational scope is a prerequisite requirement.Enterprises bear the responsibility to thoroughly review inspection standards, establish a transparent evidence document system on-site, and register technical catalogs compatible with actual operational capacity to guarantee the licensing process transpires favorably and on schedule.   

This article is for informational purposes only and does not replace professional legal advice. For support tailored to your situation, please contact HMLF lawyers.

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