Healthcare Facility Licensing in Nepal

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1. Introduction

Healthcare facility licensing is a mandatory legal requirement for all hospitals, clinics, diagnostic centers, and health service providers operating in Nepal. Governed by the Ministry of Health and Population (MoHP) and enforced by the Department of Health Services (DoHS), the licensing process ensures that healthcare facilities meet minimum standards for patient safety, infrastructure, clinical care, and public health compliance. This comprehensive guide explains the legal framework, eligibility, documents, process, cost, timeline.

2. Legal Framework Governing Healthcare Facility Licensing

Primary Laws

• Health Service Act, 2075 (2018)

• Public Health Act, 2018

• Clinical Establishment Directive (MoHP)

• Medical Education Regulations

• Patient Safety and Quality Assurance Standards

Supporting Regulations

• Health Service Regulations

• Minimum Service Standards for Hospitals & Clinics

• Ethical Standards for Healthcare Providers

• Infection Prevention & Control Guidelines

These laws govern licensing, operational standards, quality control, and accountability for health facilities and professionals.

3. Key Legal Provisions

✔ Mandatory Licensing

All healthcare facilities must obtain a license before providing services—failure to do so may result in closure, penalties, or criminal liability.

✔ Compliance with Standards

Licensed facilities must meet defined standards for:

• Infrastructure

• Staffing and qualifications

• Equipment and supplies

• Patient safety

• Infection control

• Record keeping

✔ Continuous Monitoring

Facilities are subject to periodic inspection and quality assessment by regulatory authorities.

✔ Penalties for Non-Compliance

Non-licensed operation or failure to adhere to standards can trigger:

• Fines

• Suspension of operations

• Legal prosecution

4. Administrative Authorities Involved

• Ministry of Health and Population (MoHP) – Policy and oversight

• Department of Health Services (DoHS) – Licensing authority

• Health Facility Licensing and Registration Division

• Provincial Health Directorates

• Municipality / Metropolitan City Office (for local compliance)

• Nepal Health Professional Council (for credential verification)

The DoHS is the principal authority issuing and renewing healthcare facility licenses.

5. Healthcare Facility Licensing in Nepal

What is Healthcare Facility Licensing?

A legal authorization that allows hospitals, clinics, and health centers to operate in Nepal.

Why is it Required?

To ensure standardized healthcare services, patient safety, infrastructure compliance, and regulatory accountability.

Who Needs It?

• Hospitals (private/public)

• Clinics and polyclinics

• Diagnostic centers

• Maternity homes

• Specialized care centers

Where to Apply?

At the Department of Health Services (DoHS) or provincial health directorate.

When is it Required?

Before commencing clinical operations or offering patient services.

How to Obtain It?

By submitting application, documents, site verification, and fulfilling MoHP standards.

6. Eligibility Criteria

A healthcare facility must satisfy the following to qualify for licensing:

• Registered legal entity in Nepal

• Prescribed minimum infrastructure standards

• Qualified health professionals with valid Nepal licenses

• Adequate equipment and medical supplies

• Clean and safe environment

• Compliance with infection prevention protocols

• Payment of applicable fees

Additional requirements exist for specialized or tertiary care hospitals.

7. Documents Required

Healthcare licensing application typically includes:

• Health facility registration form

• Company or organization registration certificate

• PAN/VAT registration certificate

• Land/Building ownership or lease documents

• Floor plan and building layout

• List of health professionals with valid licenses

• Staffing and duty roster

• Medical equipment and inventory list

• Infection Prevention & Control plan

• Waste management plan

• Emergency preparedness plan

• Fire safety certificate

• Patient record-keeping protocols

For specialized services (ICU, surgical units), additional technical certifications are required.

8. Step-by-Step Licensing Process in Nepal

Step 1: Prepare Documents

Collect all legal, technical, and professional documents.

Step 2: Submit Application

Submit application to the Department of Health Services (DoHS) or provincial office.

Step 3: Administrative Review

The Department verifies completeness and eligibility.

Step 4: Site Inspection

Regulatory officials conduct on-site inspection for:

• Building standards

• Medical equipment

• Staffing adequacy

• Safety and hygiene compliance

Step 5: Technical Evaluation

Specialized evaluation by clinical experts—especially for larger hospitals.

Step 6: License Issuance

Upon satisfying all criteria, the health facility license is issued.

Step 7: Operation & Compliance

Maintain standards and submit regular reports to authorities.

9. Cost of Healthcare Facility License

Costs vary with the type and size of facility:

• Application fee: NPR 5,000 – NPR 50,000

• Inspection fee

• Annual license fee

• Professional certification charges

• Fire and safety compliance charges

• Renewal charges

Additional costs apply for tertiary care services, ICU licensing, and specialized departments.

10. Timeline

• Document Preparation: 1–2 weeks

• Application Submission: Immediate

• Administrative Review: 2–4 weeks

• Inspection & Evaluation: 2–6 weeks

• License Issuance: Within 1–3 months (average)

Complex facilities like multi-specialty hospitals may take longer.

11. Other Compliance Obligations

After licensing, a facility must adhere to:

• Annual renewal of license

• Periodic inspections by DoHS

• Quality assurance reporting

• Patient safety audits

• Infection control audits

• Professional license renewals

• Waste disposal compliance

Non-compliance may lead to suspension or penalties.

12. FAQs 

1. Is healthcare facility licensing mandatory in Nepal?

Yes. All hospitals, clinics, and diagnostic centers must obtain a license before operating.

2. Who issues healthcare facility licenses?

The Department of Health Services (DoHS) under the Ministry of Health and Population.

3. What is required to open a clinic in Nepal?

Legal entity registration, infrastructure, qualified professionals, valid licenses, and DoHS approval.

4. How long does it take to get a hospital license?

Typically 1–3 months, depending on facility size and compliance.

5. Does a diagnostic center need a separate license?

Yes. Diagnostic and pathology centers require specific licensing.

6. What happens if a facility operates without a license?

The facility may be fined, closed, or face legal action.

7. How often must the license be renewed?

Typically annually, subject to regulatory standards.

13. Disclaimer

This guide is provided for general informational purposes and does not constitute legal advice. Regulatory standards and processes may change. Healthcare facility licensing requirements vary by service type and size. For specific legal consultation and compliance support in Nepal, consult a licensed healthcare attorney or contact the Department of Health Services.