Article 4 of the Saudi Medical Devices Law
المادة 4 من نظام الأجهزة والمستلزمات الطبية
The article requires the Food and Drug Authority to approve the technical and clinical specifications of radioactive medical materials before they are licensed by the Nuclear and Radiological Regulatory Commission.
Official text (Arabic)
This article has not been amended since the law was issued.
مع مراعاة اختصاصات هيئة الرقابة النووية والإشعاعية بإصدار التراخيص اللازمة لممارسة الأنشطة المتعلقة باستخدام المواد الطبية المشعة؛ يشترط موافقة الهيئة على المواصفات الفنية والإكلينيكية لتلك المواد قبل ترخيصها من هيئة الرقابة النووية والإشعاعية.
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 governs the relationship between two regulators regarding radioactive medical materials, which under Article 1 are materials from which ionizing radiation is emitted, alone or within medical devices or supplies, and which are used for diagnosis and treatment.
- The Nuclear and Radiological Regulatory Commission remains responsible for issuing the licenses needed to carry out activities relating to the use of these materials. The article respects this jurisdiction and does not take it away.
- The Saudi Food and Drug Authority must first approve the technical and clinical specifications of those materials, which by definition are the standards that determine the quality, effectiveness and safety of using the radioactive material in medical applications.
The order the article imposes is therefore clear: the Food and Drug Authority's approval of the specifications comes before the license from the Nuclear and Radiological Regulatory Commission. Anyone who wants to use a radioactive medical material needs to go through both bodies.
Article 5 completes this division by providing that applying the Law does not affect the Nuclear and Radiological Regulatory Commission's jurisdiction to issue the license for protection from ionizing radiation emitted by medical devices. Article 6 also refers to taking this article into account when applying the registration and licensing requirement.
Practical example
A private hospital in Riyadh wants to use a new radioactive material in heart imaging. Before it can obtain the Nuclear and Radiological Regulatory Commission's license for the activity, the Saudi Food and Drug Authority must have approved the technical and clinical specifications of that material.
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 Medical Devices Law
Who licenses radioactive medical materials in Saudi Arabia?
The Nuclear and Radiological Regulatory Commission is responsible for issuing licenses for activities relating to their use, after the Saudi Food and Drug Authority approves their technical and clinical specifications.
What is the Food and Drug Authority's role for radioactive materials?
The article requires its approval of the technical and clinical specifications of radioactive medical materials before they are licensed by the Nuclear and Radiological Regulatory Commission.
More articles on Scope and Definitions of the Medical Devices Law
- Article 1
The article defines the key terms of the Medical Devices and Supplies Law, such as medical device, medical supply, adulterated, establishment, authorized representative, marketing authorization and safety alert.
يقصد بالكلمات والعبارات الآتية -أينما وردت في هذا النظام- المعاني المبينة أمام كل منها، ما لم يقتض السياق غير ذلك: النظام: نظام الأجهزة والمستلزمات الطبية. الهي
- Article 2
The article lists eight activities that are subject to the Medical Devices and Supplies Law, from design, manufacturing and importing to maintenance and representing a foreign manufacturer.
تخضع لأحكام النظام الأنشطة الآتية: 1- تصميم الأجهزة والمستلزمات الطبية، وتصنيعها. 2- استيراد الأجهزة والمستلزمات الطبية، وتسويقها، وتوزيعها، وتخزينها. 3- تقديم
- Article 3
The article treats accessories of medical devices and supplies, and assembled devices, as medical devices and supplies subject to the Law's provisions.
تعد في حكم الأجهزة والمستلزمات الطبية الخاضعة لأحكام النظام: ملحقاتها، والأجهزة والمستلزمات الطبية المجمعة.
- Article 5
The article preserves the Nuclear and Radiological Regulatory Commission's jurisdiction to issue the license for protection from ionizing radiation emitted by medical devices, without the Law affecting it.
لا يخل تطبيق أحكام النظام، باختصاصات هيئة الرقابة النووية والإشعاعية فيما يتعلق بإصدار ترخيص الحماية من الإشعاع المؤين الصادر من الأجهزة الطبية.
- Article 48
The article requires the Board to issue the Implementing Regulations within 180 days of the Law's publication in the Official Gazette, to take effect from the date the Law takes effect.
يصدر المجلس اللائحة خلال (مائة وثمانين) يومًا من تاريخ نشر النظام في الجريدة الرسمية، ويعمل بها من تاريخ نفاذه.
- Article 49
The article sets the start of effect of the Medical Devices and Supplies Law at 180 days after its publication in the Official Gazette.
يعمل بالنظام بعد (مائة وثمانين) يومًا من تاريخ نشره في الجريدة الرسمية.
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.