First: Requirements for Initial Approval
This stage aims to verify the investor’s eligibility and the suitability of the site before starting construction or preparation work.
- Legal Documents:
- Commercial Register: The establishment’s commercial register must be valid and include the activity “Hearing Disease Treatment Center.”
- Title Deed or Lease Contract: Provide a copy of the title deed or lease contract for the site, with the lease contract valid for no less than 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 center, approved by an engineering office. The plans must show:
- Hearing test rooms (soundproof rooms).
- Patient examination rooms.
- Patient waiting areas.
- Area for displaying and selling medical hearing aids.
Second: Requirements for Final Operating License
After obtaining initial approval and completing construction and preparation work, this stage is undertaken to obtain the final license.
- Engineering and Technical Requirements:
- Building Permit: Provide 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.
- Soundproof Rooms: Hearing test rooms must be fully soundproofed and comply with international technical standards to ensure accurate examinations.
- Infection Control System: Have an integrated infection control system, including a medical waste disposal system in accordance with standards.
- Specialized Staff:
- Technical Director: The center’s technical director must be Saudi, a hearing specialist, hold a valid professional classification from the Saudi Commission for Health Specialties, and have at least two years of practical experience.
- Technical Staff: All specialists must hold valid professional classifications from the Saudi Commission for Health Specialties.
- Ratio and Proportion: Adhere to the minimum required staffing levels relative to the size of the center.
- Equipment and Facilities:
- Hearing Devices: Provide specialized hearing devices for hearing assessment, such as an Audiometer, Tympanometer, and Auditory Brainstem Response (ABR) device.
- Hearing Aid Models: Provide various models of medical hearing aids.
- Additional Requirements:
- Insurance Document: Obtain medical malpractice insurance.
- Accreditation: Obtain accreditation from the Saudi Central Board for Accreditation of Healthcare Institutions (CBAHI), which is a mandatory requirement for operation.
- Referral Agreements: The center must have an agreement with a nearby hospital or medical complex to transfer cases requiring surgical intervention or advanced medical care.
- Compliance with Standards: The center must comply with the technical standards for hearing assessment and fitting medical hearing aids.