First: Requirements for Preliminary Approval
This stage aims to verify the investor’s eligibility and the site’s suitability before starting construction or renovation.
- Legal Documents:
- Commercial Registration: The facility must have a valid commercial registration including the activity "Medical Laboratory".
- Ownership Deed or Lease Contract: Submit a copy of the ownership deed or lease contract for the site. The lease must be for a minimum of 5 years.
- 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 laboratory, approved by an engineering office. The plans must show:
- Different laboratory departments (e.g., Biochemistry, Microbiology, Hematology).
- Sample collection rooms.
- Storage rooms.
- Reception and waiting areas.
- Ventilation and infection control systems.
Second: Requirements for Final Operating License
After obtaining preliminary approval and completing construction and outfitting, this stage begins to obtain the final operating license.
- Engineering and Technical Requirements:
- Building Permit: Submit a copy of the building permit issued by the Ministry of Municipal and Rural Affairs and Housing.
- Civil Defense Approval: Obtain approval from the General Directorate of Civil Defense.
- Infection Control System: Implement a comprehensive infection control and sterilization system, including proper disposal of medical waste according to standards.
- Ventilation and Safety: All sections must have adequate ventilation, lighting, and high safety procedures for handling samples and chemicals.
- Specialized Staff:
- Technical Director: Must be a Saudi national, a consultant or specialist in medical laboratories, with a valid professional classification from the Saudi Commission for Health Specialties.
- Technical Team: All laboratory technicians must have a valid professional classification from the Saudi Commission for Health Specialties.
- Staffing Ratios: Maintain the minimum required technical and administrative staff.
- Equipment and Facilities:
- Medical Devices: All laboratory and medical devices must be modern and approved by the Saudi Food and Drug Authority (SFDA).
- Chemicals and Reagents: Provide all necessary chemicals and reagents for laboratory analyses.
- Quality System: Implement an internal quality control system to ensure accuracy and reliability of results.
- Laboratory Information System (LIS): Provide a system for managing lab information, facilitating sample tracking and reporting results.
- Additional Requirements:
- Insurance: Obtain medical malpractice insurance.
- Accreditation: Obtain accreditation from the Saudi Center for Accreditation of Healthcare Institutions (CBAHI), which is mandatory for operation.
- Participation in Quality Program: The laboratory must participate in an external quality control program.