• The following terms wherever mentioned in the Regulation shall have the meanings indicated opposite them:

  • A- Law: Private Laboratories Law.
  • B- Competent Authority: Ministry of Interior, Ministry of Commerce, Ministry of Health, Ministry of Environment, Water, and Agriculture, Ministry of Industry and Mineral Resources, Ministry of Municipal and Rural Affairs and Housing, Ministry of Energy, Saudi Food and Drug Authority, General Authority for Military Industries, Higher Industrial Security Authority, or Saudi Standards, Metrology and Quality Organization.
  • C- Competent Official: Minister of Interior, Minister of Health, Minister of Environment, Water, and Agriculture, Minister of Industry and Mineral Resources, Minister of Municipal and Rural Affairs and Housing, Minister of Energy, Chief Executive Officer of the Saudi Food and Drug Authority, Governor of the General Authority for Military Industries, Chairman of the Board of the Higher Industrial Security Authority, or Governor of the Saudi Standards, Metrology and Quality Organization.
  • D- Goods: Goods produced locally or imported, whether in the form of materials, products, devices, tools, or others.
  • E- Sample: Samples withdrawn on scientific bases according to the approved standard specifications.
  • F- Test: Any analysis, calibration, or examination aimed at determining components, characteristics, performance efficiency, effectiveness, or conformity.
  • G- Laboratory: Any place prepared for testing any goods or calibrating any device.
  • H- Accreditation Certificate: An accreditation certificate granted by the Saudi Accreditation Center according to the requirements of the Laboratory Accreditation Regulation and the Saudi Standard Specifications ISO 17025.
  • I- Approved Standard Specifications: Saudi Standard Specifications or Gulf Standard Specifications, and in the absence of Saudi or Gulf standard specifications, any standard specifications adopted by the Board of Directors of the Saudi Standards, Metrology and Quality Organization, or the Board of Directors of the Saudi Food and Drug Authority, or the Board of Directors of the General Authority for Military Industries, according to the jurisdiction.

• The following entities are competent to issue licenses for private laboratories:

  • A- Ministry of Interior: Private laboratories for civil explosives.
  • B- Ministry of Environment, Water, and Agriculture: Private laboratories for goods listed in paragraph (B) of Article Nine.
  • C- Ministry of Energy: Private laboratories for petroleum, gas, their derivatives, and petrochemical materials.
  • D- Saudi Food and Drug Authority: Private laboratories for pharmaceuticals, pharmaceutical, biological, veterinary, biological, and health preparations, cosmetic preparations and products, laboratories for food, feed, herbs, and medicinal plants, laboratories for medical devices and supplies, laboratories for pesticides, tobacco, and its products.
  • E- General Authority for Military Industries: Private laboratories for military and security explosives and materials related to these products in the fields of military industry.
  • F- Supreme Industrial Security Authority: Private laboratories for chemicals used in the manufacture of explosives or explosives and chemical precursors, devices, equipment, and apparatus in the fields of industrial security.
  • G- Saudi Standards, Metrology and Quality Organization: Private laboratories for all goods except those mentioned in the previous paragraphs of this article.

• The competent official shall issue a decision specifying the department responsible for issuing the licenses.

• Laboratory license applications shall be submitted to the competent administration, which is determined by a decision of the authorized official, and the application shall include the following:

  • A- Filling out the approved license application form.
  • B- Submitting a project study that includes the estimated costs, technical staff, and equipment.
  • C- The license applicant's commitment to provide the necessary qualified specialists, equipment, and devices required for the laboratory work in accordance with the volume and nature of the work, as determined by the competent authority and the center.

The relevant department shall study the claim and make a decision within thirty days from the date of its submission. In the event of acceptance, the applicant shall be granted a preliminary license that allows them to complete the requirements for obtaining the final license. In the case of rejection, the decision shall be reasoned, and the license applicant has the right to appeal the decision before the competent minister within the time period specified by law.

• The licensee is granted a period not exceeding one and a half years to complete the following accreditation requirements:

  • A- The organizational structure of the laboratory.
  • B- Identification of the technical staff necessary to operate the laboratory, along with a certified copy of their academic qualifications, experiences, and training courses.
  • C- Identification of the devices and equipment necessary to operate the laboratory.
  • D- Submission of a municipal license or approval from the competent authority authorizing the practice of the activity at this location.
  • E- Accreditation certificate from the center.

The preliminary license shall be revoked if six months pass without fulfilling the requirements stated in Article Five.

The competent Minister or his delegate shall issue the license for the laboratory to conduct the activity after fulfilling the following:

• A- Completing the requirements stated in Article Five.

• B- Specifying the types of goods and tests and the maximum cost for each test required for licensing after obtaining the approval of the competent Minister on the Committee's recommendation.

• C- Paying the license fee, which amounts to five thousand Riyals for the main laboratory, and two thousand five hundred Riyals for each branch.