First: Requirements for Initial Approval
This stage aims to verify the investor’s eligibility and the site’s suitability before starting the setup works.
  • Legal Documents:
    • Commercial Registration: The facility’s commercial registration must be valid and include the activity "Home Medical Services Center".
    • Title Deed or Lease Agreement: Provide a copy of the title deed or lease for the administrative office that will serve as the center’s headquarters.
  • Site and Plans:
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
    • Preliminary Engineering Plans: Submit preliminary engineering plans for the administrative office, certified by an engineering office. The plans must show:
      • Administrative offices.
      • Room for storing medical supplies.
      • Waiting area for visitors (if applicable).
Second: Requirements for Final Operating License
After obtaining initial approval and completing the setup, this stage is for obtaining the final operating license.
  • Administrative and Technical Requirements:
    • Municipality License: Submit a copy of the municipality license issued by the Ministry of Municipal and Rural Affairs and Housing for the administrative office.
    • Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
    • Infection Control System: A written and clear protocol for infection control and sterilization, including a safe system for medical waste disposal according to standards.
  • Specialized Staff:
    • Medical Director: The medical director must be Saudi and a physician in one of the following specialties: Family Medicine, Internal Medicine, Intensive Care, or Emergency Medicine. They must have a valid professional classification from the Saudi Commission for Health Specialties.
    • Medical Team: The team must include physical therapists, nurses, and technicians, all with valid professional classification from the Saudi Commission for Health Specialties.
    • Staffing Ratio: Adhere to the minimum required medical staff to operate the center.
  • Facilities and Equipment:
    • Medical Supply Depot: The office must have a storage area equipped with all necessary medical supplies, with suitable air conditioning, lighting, and temperature monitoring (not exceeding 25°C).
    • Records System: Provide an electronic system to document patient information in a unified medical file, ensuring data privacy and security.
    • Medical Devices: Provide essential medical devices required by the medical team during home visits (e.g., blood pressure monitors, glucose meters, oxygen devices).
  • Additional Requirements:
    • Insurance Certificate: Obtain malpractice/medical errors insurance.
    • Accreditation: Obtain accreditation from the Saudi Center for Accreditation of Healthcare Institutions (CBAHI), mandatory for operation.
    • Referral Agreements: The center must have a signed agreement with a hospital for patient referrals or medical consultations as needed.
    • Work Protocols: The center must have clear protocols to determine a care plan for each patient before every home visit.
First: Requirements for Initial Approval
This stage aims to verify the investor’s eligibility and the suitability of the headquarters before starting the setup works.
  • Legal Documents:
    • Commercial Registration: The facility’s commercial registration must be valid and include the activity "Remote Care and Telemedicine Center".
    • Title Deed or Lease Agreement: Provide a copy of the title deed or lease for the administrative office that will serve as the center’s headquarters.
  • Site and Plans:
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing for the site.
    • Preliminary Engineering Plans: Submit preliminary engineering plans for the administrative office, certified by an engineering office. The plans must show:
      • Administrative offices.
      • Rooms for healthcare practitioners.
      • Technical equipment areas.
Second: Requirements for Final Operating License
After obtaining initial approval and completing the setup, this stage is for obtaining the final operating license.
  • Technical and Administrative Requirements:
    • Digital Platform: The center must have a licensed and approved digital platform or application by the Ministry of Health and the National Health Information Center, ensuring patient data confidentiality and security.
    • Documentation System: The platform must be capable of documenting all consultations, including patient identity, type of technology used, date and time of the consultation, and medical recommendations.
    • Data Security: All medical data and information must be fully encrypted and stored securely within the Kingdom of Saudi Arabia.
    • Infection Control System: A written protocol must exist to ensure sterilization and hygiene when using any medical tools.
  • Specialized Staff:
    • Technical Director: The center’s technical director must be a physician in a specialty relevant to the type of consultations provided, with a valid professional classification from the Saudi Commission for Health Specialties.
    • Healthcare Practitioners: All healthcare practitioners working in the center (physicians, pharmacists, specialists) must hold a valid professional classification from the Saudi Commission for Health Specialties.
  • Facilities and Equipment:
    • Administrative Headquarters: The administrative office must be fully equipped and include rooms dedicated for healthcare practitioners to conduct consultations.
    • Technical Equipment: Provide computers, cameras, and high-quality audio systems to ensure effective communication with patients.
  • Additional Requirements:
    • Insurance Certificate: Obtain malpractice/medical errors insurance.
    • Accreditation: Obtain accreditation from the Saudi Center for Accreditation of Healthcare Institutions (CBAHI), which is mandatory for operation.
    • Clear Policies: The center must have clear policies and guidelines for handling emergency cases and informing patients about health conditions that require an in-clinic or hospital visit.
    • Prior Consent: Obtain prior consent from the patient before any remote medical consultation, preferably electronically.
First: Requirements for Basic License (Administrative Headquarters)
  • Commercial Registration: The facility’s commercial registration must be valid and include the activity "Mobile Medical Services Center".
  • Administrative Headquarters: The center must have a fixed administrative headquarters, which must comply with the same requirements as medical complexes or clinics, including:
    • Title Deed or Lease: Provide a copy of the title deed or lease for the site.
    • Municipality Approval: Obtain approval from the Ministry of Municipal and Rural Affairs and Housing.
    • Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
  • Staff:
    • Medical Director: The medical director must be Saudi and hold a valid professional classification from the Saudi Commission for Health Specialties.
    • Medical Team: All healthcare practitioners working in the center must hold a valid professional classification.
  • Accreditation:
    • CBAHI: The center must obtain accreditation from the Saudi Center for Accreditation of Healthcare Institutions (CBAHI).
Second: Requirements for Licensing Mobile Medical Units
In addition to licensing the administrative headquarters, each mobile medical unit must be licensed separately and comply with the following requirements:
  • Vehicle:
    • Traffic License: The vehicle must be owned by the center’s owner, and its traffic license must be valid.
    • Technical Specifications: The vehicle must be equipped according to the technical specifications set by the Ministry of Health, including:
      • Suitable for fieldwork.
      • Equipped with a thermally insulated box, with proper lighting and ventilation.
      • Walls and floors made of easy-to-clean materials.
      • Clearly display the center’s name and license number.
  • Equipment and Facilities:
    • Electric Generators: The unit must have an independent power generator.
    • Air Conditioning and Lighting: Both systems must be functional and adequate.
    • Water Supply: Provide a fresh water source, a washing sink, and a restroom (for certain types of units).
    • Medical Supplies: Provide storage for medical supplies and a dedicated cabinet for emergency medications.
  • Services Provided:
    • Operational Plan: The center must submit a clear operational plan to the local or regional health authority, outlining the scope of the mobile unit and the services it will provide (it is not allowed to operate outside the licensed area).
    • Type of Services: The center must specify the type of services to be provided (e.g., primary care, general check-ups, vaccinations).
    • Records: The center must have an electronic system for documenting patient information in a unified health record.
    • Referral: The center must have a contract with a hospital in the health insurance network for referring cases requiring advanced care.
  • Insurance:
    • Insurance Certificate: Obtain malpractice/medical errors insurance.