Article 4 of the Saudi Private Laboratories Law
المادة 4 من نظام المختبرات الخاصة
The article refers to the Implementing Regulations the determination of laboratory categories and the conditions for each category, on the recommendation of the Saudi Accreditation Center.
Official text after amendments (Arabic)
Compiled from the original text and every officially published amendment; the amendments are shown in full below for comparison.
تحدد اللائحة التنفيذية فئات المختبرات والشروط اللازم توافرها لكل فئة، بناءً على توصية من المركز.
This is the official Arabic wording, the only legally binding version. We do not translate the law itself; the explanation below is ours. Official source: Bureau of Experts at the Council of Ministers
Article 4 explained in plain English
This article does not itself set the categories of laboratories or their conditions, but refers that to the Law's Implementing Regulations. That means private laboratories are not all of one grade, and each category has its own conditions.
The article contains two matters:
- The Implementing Regulations are what determine the categories of laboratories.
- The Regulations are what determine the conditions required for each category.
This is on the recommendation of the Center, which under Article 1 is the Saudi Accreditation Center, so the Center's technical opinion is the basis on which these conditions are built.
This article was amended by Royal Decree No. M/31 dated 6/4/1443 AH, and the text presented is the text in force.
The article is related to Article 3, which requires, for licensing, providing qualified staff and the necessary equipment as determined by the competent authority and the Center, and to Article 5, which also refers to the Regulations the determination of the procedures for obtaining the licence and the period for considering the application. The Law itself does not state the names of the categories or the details of their conditions, so the reference for them is the Implementing Regulations.
Translated from our Arabic explanation with machine assistance. For guidance only; it does not replace advice from a lawyer on your situation.
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Frequently asked questions about Article 4 of the Saudi Private Laboratories Law
Who determines the categories of private laboratories?
The Implementing Regulations of the Law determine them, on the recommendation of the Saudi Accreditation Center.
Are the licence conditions the same for all laboratories?
The article provides that the Regulations determine the conditions required for each category of laboratories, and their details are found in the Regulations.
Amendment history
Royal Decree No. M/31 — 6/4/1443 AH
Official amendment text (Arabic)
- عُدلت هذه المادة وذلك بموجب المرسوم الملكي رقم (م/31) وتاريخ 1443/4/6هـ، لتكون بالنص الآتي:
" تحدد اللائحة التنفيذية فئات المختبرات والشروط اللازم توافرها لكل فئة، بناءً على توصية من المركز".
Original text before the amendments (Arabic)
تحدد اللائحة التنفيذية فئات المُختبرات والشروط اللازِم توافُرها لكُل فئة، بناءً على توصية من الهيئة.
More articles on Private Laboratory License
- Article 3Amended by M/31
The article requires, for licensing a laboratory, a commitment to provide qualified specialist staff and the necessary equipment and devices as determined by the competent authority and the Center.
يُمنح الترخيص للمختبرات بشرط التزام الترخيص بتوفير الكوادر اللازمة من المتخصصين المؤهلين علمياً، والمعدات والأجهزة اللازمة للعمل بالمختبر بما يتفق مع حجم العمل
- Article 5
The article refers to the Implementing Regulations the determination of the procedures for obtaining a private laboratory licence and the period needed to consider the application.
تُحدد اللائحة التنفيذية إجراءات الحصول على الترخيص، والمدة اللازمة لدراسة الطلب.
- Article 6Amended by M/31
The article gives the licensed laboratory a period of no more than a year and a half from the date of the licence to obtain accreditation from the Center, failing which the licence is considered cancelled.
يُعطى المرخص له مهلة لا تزيد على سنة ونصف تبدأ من تاريخ حصوله على الترخيص لإكمال الحصول على الاعتماد من المركز. وفي حال انقضاء المهلة دون الحصول على الاعتماد يع
- Article 7Amended by M/31
The article sets the private laboratory licence fee at SAR 5,000 for the main laboratory and SAR 2,500 for each branch, a licence period of five years, and how it is renewed.
أ- تصدر الجهة المختصة الترخيص للمختبر الخاص بعد تسديد رسم الترخيص، ومقداره خمسة آلاف (5000) ريال للمختبر الرئيس، وألفان وخمسمائة (2500) ريال لكل فرع. ب- مدة صلا
The texts are reproduced from the official website of the Bureau of Experts at the Council of Ministers for reference; where they differ, the officially published Arabic text prevails. This content is not legal advice.