The private healthcare services market, including clinics, private hospitals, and remote medical services, is experiencing rapid growth. However, it is also a highly specialized sector subject to frequent regulatory compliance audits by competent authorities. In practice, many medical establishments face prolonged licensing procedures or even post inspection administrative penalties. The root causes usually stem not from a lack of medical expertise, but rather from inaccurate legal files, actual staffing configurations that do not align with the registered scope of practice, or operating beyond licensed boundaries.

1. Operating Licenses for Clinics: Core Conditions to Meet

Depending on the specific type of clinic, such as specialized clinics, polyclinics, dental clinics, cosmetic clinics, or traditional medicine establishments, the mandatory conditions may vary. However, licensing authorities typically evaluate applications based on three core pillars.

1.1. Physical Facilities and Equipment Conditions

Physical infrastructure and facilities are the primary factors reviewed during audits to guarantee patient safety.

• Premises and Functional Layout: Medical organizations must ensure that their functional spaces are designed and partitioned clearly, meeting rigorous standards for sanitation and infection control. Pursuant to Decree No. 96/2023/NĐ-CP of the Government, a standard consultation room must have a minimum floor area of 10 square meters.
• Technical Equipment: The establishment must be fully equipped with the minimum list of medical devices and machinery corresponding to its registered scale and scope of professional activities. All equipment must have clear documents proving legal origin and must undergo periodic calibration and safety testing.
• Medical Waste Management: Businesses must formulate a compliant and efficient medical waste treatment plan. Depending on the specific case, clinics must execute a waste collection contract with licensed waste disposal entities or establish standard on site storage processes.

1.2. Professional Staffing Conditions

Human resources determine the capacity of a private medical establishment to deliver legal healthcare services.

• Person in Charge of Professional and Technical Aspects: This is the pivotal position that dictates the legality of the licensing dossier. This individual must possess sufficient practicing experience and must register to work on a full time basis at the establishment.
• Core Medical Staff: The practicing doctors, nurses, and technicians working at the clinic must perfectly align with their registered job titles, practicing certificates, and professional scopes of activity.
• Labor Management Files: The enterprise must prepare valid labor contracts, assignment decisions, specific shift schedules, and clear professional assignment documents for each practicing member.

1.3. Professional Scope and Internal Protocols

Clear delineation of services prevents clinics from committing unauthorized beyond scope violations.

• Technical List: Establishments must identify and compile the exact list of technical procedures and medical services they intend to perform in practice.
• Technical Protocols and Internal Operating Rules: Clinics must formulate specific professional protocols, internal operating regulations, medical record management procedures, prescription rules, and medicine management workflows.

Crucial note: Many licensing dossiers are delayed or rejected because establishments register a scope of practice that is too broad relative to their actual space, staff, or equipment. The safest and most strategic approach for businesses is to register only for services within their immediate capacity, and then perform license adjustments and additions as the business stabilizes and accumulates the necessary resources.

2. Clinic Operating License Dossier

Although local Departments of Health may require different templates or specific presentation formats, a standard application dossier for an operating license consistently contains several foundational elements.

2.1. Standard Dossier Components

Enterprises should crosscheck the following list of documents thoroughly before submitting their application:

• An application form for a medical operating license prepared in accordance with the prescribed legal templates.
• Legal documents proving the lawful right to use the premises, including notarized land or property lease agreements or ownership certificates, accompanied by architectural floor plans and functional descriptions of each room.
• A detailed list of medical equipment intended for use, specifying technical parameters, quantities, and actual operational status.
• A list of registered practitioners showing their professional titles, registered working hours, attached practicing certificates, and valid labor relationship documents.
• A detailed explanation of the professional scope and technical lists requested for approval.
• Technical protocols, internal regulations, and quality management files depending on the scale and operational model of the clinic.

2.2. Common Dossier Rejection Grounds

Practical experience indicates that competent authorities frequently reject dossiers due to recurring issues:

• Staffing Inconsistencies: Practicing certificates do not satisfy the minimum duration or experience requirements, or the certified scope of practice does not cover the registered technical services.
• Architectural Inadequacies: Floor plans lack necessary details, functional areas fail to separate clean and dirty pathways, or consultation rooms do not meet the minimum space specifications.
• Inadequate Equipment Proof: Equipment is listed extensively in the dossier but lacks documents proving lawful origin, or the technical specifications do not align with the requested scope of practice.
• Unrealistic Technical Lists: Registering complex technical lists that are too extensive and disproportionate to the actual operational capacity and model of a clinic.
• Absence of Essential Internal Guidelines: Failure to submit mandatory internal operating procedures, such as medical record archiving, infection control, or medical incident response workflows.

3. Licensing Timelines: Realistic Expectations and Acceleration Strategies

The processing time for an operating license generally depends on the completeness of the initial application, the inspection schedule of the competent evaluation committee, and the duration required for the clinic to explain or rectify deficiencies identified during the review process.

3.1. Authority Decentralization under the Latest Regulations of 2025

The introduction of Decree No. 148/2025/NĐ-CP of the Government has established a thorough decentralization mechanism in the healthcare sector. As of 2026, the authority to receive dossiers, evaluate, issue, adjust, suspend, and revoke operating licenses for most private clinics and hospitals has been transferred directly to the heads of provincial level medical agencies, namely the local Departments of Health. This decentralization eliminates multiple bureaucratic layers, saving significant time for businesses.

3.2. Methods for Optimizing Wait Times

To minimize licensing delays, clinic owners should proactively implement rigorous preparatory steps:

• Standardize the entire application dossier from the outset based on a precise and comprehensive checklist.
• Prepare clear and transparent human resource evidence, including labor contracts, appointment decisions, and shift schedules that do not overlap with the working hours of other public or private institutions.
• Conduct thorough internal mock inspections before the official evaluation committee arrives, focusing on signage, room dimensions, equipment readiness, archiving procedures, and infection control compliance.

4. Staffing Conditions and Practicing Certificates: Primary Focus Areas of Inspectorates

Even after a clinic has obtained its official operating license and commenced operations, specialized inspection teams will continue to scrutinize human resource aspects closely during routine or snap audits.

4.1. Focus Areas of Specialized Inspections

Auditing teams typically seek to identify and gather evidence on the following violations:

• Verification of whether the licensed medical director is physically present and managing operations in accordance with the registered working hours.
• Verification of whether all practicing personnel possess valid practicing certificates that correspond to their current duties and ensure that these certificates remain legally active.
• Detecting and heavily penalizing cases of certificate renting or medical staff who sign paper contracts for dossier compliance but do not actually work on site.
• Reviewing medical logs and records to verify that assigned duties and performed procedures do not exceed the scope defined in the practitioner’s certificate.

4.2. Continuous Medical Education (CME) Obligations

Medical practitioners working in private establishments must comply with continuous medical education requirements. Under Circular No. 32/2023/TT-BYT of the Ministry of Health, practicing personnel must participate in training courses to accumulate at least 120 credit hours within a continuous five year cycle. Failure to manage and enforce this requirement may expose the establishment to the risk of having its clinical operations suspended.

4.3. Recommendations for Secure Operations

To protect the enterprise during inspections, clinic management must systematically archive all labor files, including employment contracts, professional duty assignments, shift logs, and actual timecards. Furthermore, clinics must establish and enforce strict internal controls to ensure that no medical services are performed beyond the officially approved scope of practice.

5. Opening a Polyclinic: Mandatory Departments and Rooms

Unlike specialized clinics, the polyclinic model demands a significantly more complex and strictly partitioned functional layout. The following approach provides a compliant architectural design framework for investors.

5.1. Specialty Configuration Requirements

Polyclinics must specify the exact clinical specialties they intend to operate. According to Decree No. 96/2023/NĐ-CP of the Government, a recognized polyclinic must operate at least two out of the four foundational specialties, which include internal medicine, surgery, obstetrics gynecology, and pediatrics. Dossiers lacking this core structure are rejected immediately. In addition to the clinical block, polyclinics must plan and integrate a complete paraclinical section, which must include both laboratory services and diagnostic imaging services.

5.2. Space Design and Functional Standards

The spatial layout of a polyclinic must provide the following mandatory functional zones:

• A spacious reception area and patient waiting lounge.
• Consultation rooms separated by solid partitions, with each specialty consultation room measuring at least 10 square meters.
• A procedure or minor surgery room with a minimum area of 10 square meters, if the clinic registers these technical services.
• An emergency or first aid room with a standard minimum area of 12 square meters.
• A patient observation room of at least 15 square meters, equipped with a minimum of two observation beds. If three or more beds are deployed, the room must expand by at least 5 square meters per additional bed.
• Essential supporting functional areas, including a medical record archive, a dedicated medical waste collection station, and a sterilization area to support infection control.

Content Marketing Strategy Tip: Healthcare consulting businesses can publish a dedicated satellite article focusing on the keyword “what rooms are required to open a polyclinic” and link it back to this pillar article to enhance online traffic and conversion.

6. M&A or Transfer of Clinics: Due Diligence Legal Checklist

When executing a merger, acquisition, or transfer of an active medical facility, investors are not merely purchasing physical assets or patient databases. The most significant legal risks usually lie in the validity of the operating license and the historical compliance of the target facility. A comprehensive legal due diligence review must cover the following aspects.

6.1. Operating License and Actual Scope of Activities

Legal teams must examine the remaining validity of the operating license, cross matching licensed services with actual clinical offerings to identify unauthorized or beyond scope activities. Reviewing historical files of previous license amendments also helps evaluate the structural stability and legality of the corporate entity.

6.2. Status of Key Personnel

Acquirers must clarify the identity and commitment of the clinic’s medical director. Formal agreements must be secured to confirm whether this key individual will continue working after the transaction concludes. The sudden departure of this figure can trigger an immediate suspension of the clinic’s operations. Additionally, the validity of all staff practicing certificates and labor contracts must be rigorously audited.

6.3. Existing Contracts and Outstanding Obligations

Due diligence experts must review the property lease agreement, checking the remaining lease term, termination clauses, and provisions regarding rent adjustments or lease transfers upon a change of clinic ownership. Commercial contracts with equipment suppliers, service providers, and insurers must also be analyzed, focusing on warranty terms, maintenance agreements, and mandatory sales quotas.

6.4. Compliance History and Penalty Risks

Compliance history reflects the quality of previous management. Investors must review historical inspection logs, administrative penalty decisions, and verify whether all rectification orders from regulators have been fully resolved. Internal workflows, medical recording practices, prescribing habits, advertising campaigns, and consent collection mechanisms must be evaluated systematically.

6.5. Medical Records and Data Privacy Risks

During an ownership transition, patient data transfer is a sensitive legal area. Under Decree No. 356/2025/NĐ-CP of the Government, health status and clinical information recorded in medical files are classified as sensitive personal data.

Acquiring entities must comply with stringent data privacy standards. The transfer of patient databases must be based on explicit, voluntary consent from the data subjects, and default opt in settings are strictly prohibited. The establishment must enforce role based access controls, deploy advanced encryption standards, and establish strict protocols to prevent unauthorized data sharing by internal staff, thereby mitigating legal liability and preventing reputational crises from sensitive data leaks.

7. When Must an Amendment of the Operating License Be Requested?

During the business life cycle, medical facilities frequently need to modify their organizational structure or expand services. The following sections outline the most common scenarios and their administrative rules.

7.1. Circumstances Requiring Administrative Adjustments

• Relocating the Clinic: When moving a clinic to a new address, the business must undergo a full reassessment and apply for a new operating license, as relocation alters the structural layout, safety conditions, and physical standards evaluated in the original application.
• Changing the Medical Director: Any change in the licensed director requires the clinic to prepare a qualification dossier for the replacement candidate and perform update procedures with the licensing authority. Under the decentralization of Decree No. 148/2025/NĐ-CP of the Government, this procedure is processed directly by the provincial Department of Health, saving significant administrative turnaround time.
• Adding or Reducing Technical Services: To expand or restrict clinical offerings, the facility must submit explanatory dossiers proving that it possesses the corresponding certified staff, necessary equipment, and standard operating protocols for the new services.

7.2. Golden Rules for Compliant Operation

Private healthcare enterprises must strictly adhere to the rule that no new medical services may be performed in practice until the competent authority has officially approved the amendment to the operating license. This is a common compliance error that often results in heavy administrative fines or clinical suspension during unannounced inspections.

8. Telehealth or Remote Medicine: Current Legal Framework and Compliance Risks

The rapid integration of technology has accelerated remote medicine offerings. However, when operating telehealth models, tech platforms and clinics must navigate three core compliance risk areas.

8.1. Organizational Conditions and Service Scope

Pursuant to Article 87 of Decree No. 96/2023/NĐ-CP of the Government, remote medical services cannot operate independently as pure tech platforms linking individual doctors directly to patients. Telehealth must be delivered by certified practitioners affiliated with a legally licensed physical medical establishment, such as a hospital or a polyclinic.

The medical facility must clearly categorize which clinical conditions can be diagnosed safely online and which require in person examinations. Moreover, the organization must monitor its marketing communications to prevent sales teams from over promising or guaranteeing medical outcomes.

8.2. Medical Protocols and Legal Liability Apportionment

The lack of physical contact necessitates precise online professional protocols. These workflows must span online registration, risk screening, diagnosis, secure electronic prescribing, and clinical record archiving. Crucially, partnership agreements must clearly delineate legal liabilities among the software provider, the medical institution, and the consulting doctor to handle malpractice claims or technical service interruptions appropriately.

8.3. Health Data Protection and Cybersecurity

Clinical histories, medical images, and treatment records are highly sensitive personal data protected by law. Telehealth operators must obtain explicit consent from patients before data collection, establish rigid access control mechanisms, maintain real time access logs, and guarantee secure cloud storage.

Under Decree No. 356/2025/NĐ-CP of the Government, telehealth operators must conduct a formal Data Protection Impact Assessment (DPIA) for their systems. In service contracts with software providers or cloud hosting partners, the clinic must incorporate robust clauses defining data processing responsibilities, mandatory encryption, and liability for data breaches.

9. Establishing Laboratory and Imaging Services: Conditions on Equipment, Personnel, and Processes

If a clinic intends to expand its paraclinical ecosystem by establishing laboratory or imaging services, such as X-ray, ultrasound, or other complex diagnostic procedures, it must fulfill strict specialized criteria.

9.1. Professional Staffing Credentials

Under current regulations, personnel managing paraclinical operations must possess advanced credentials. The medical director of a laboratory must be a doctor specializing in laboratory medicine or a technician holding at least a bachelor degree in laboratory technology. Similar requirements apply to diagnostic imaging divisions to ensure absolute accuracy in medical analyses.

9.2. Equipment Capacity and Radiation Safety

Paraclinical machinery and equipment must fully support the registered technical lists. All devices must possess documentation proving legal origin, along with routine maintenance and calibration logs. Operationally, the facility must establish strict quality control workflows, secure result delivery protocols, digital archiving procedures, and radiation safety protocols (such as lead shielded rooms for X-ray devices) to protect both technicians and patients.

10. Frequently Asked Questions (FAQ)

10.1. Why are clinic licensing dossiers commonly rejected ?

Based on practical experience, the most common reasons include discrepancies between the practitioner’s practicing certificate scope and the registered technical services, incomplete or inaccurate architectural layouts, registering a scope of practice too broad for the actual equipment capacity, and the absence of mandatory internal operating protocols.

10.2. Should a clinic register as many technical services as possible from the outset ?

This approach is strongly discouraged. Registering services beyond the actual capacity of the clinic significantly increases the risk of being requested for explanations, additional documents, or outright rejection during physical inspections, which directly prolongs the waiting time and increases opportunity costs.

10.3. Is it mandatory to adjust the operating license when there is a change in the medical director ?

Yes, this is a strict legal requirement. The medical establishment must promptly prepare a complete dossier proving the professional capacity and practicing scope of the replacement personnel and carry out the update procedures with the local Department of Health to ensure the continuous legality of business operations.

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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