Article 5 of the Saudi Medical Devices Law
المادة 5 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يخل تطبيق أحكام النظام، باختصاصات هيئة الرقابة النووية والإشعاعية فيما يتعلق بإصدار ترخيص الحماية من الإشعاع المؤين الصادر من الأجهزة الطبية.
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 5 explained in plain English
This article is a rule preserving jurisdiction. It provides that applying the provisions of the Medical Devices and Supplies Law does not affect the power of the Nuclear and Radiological Regulatory Commission to issue the license for protection from ionizing radiation emitted by medical devices.
The practical meaning is that medical devices that emit ionizing radiation, such as X-ray machines, are subject to this Law's requirements overseen by the Saudi Food and Drug Authority, and at the same time remain subject to the radiation protection license issued by the Nuclear and Radiological Regulatory Commission. Meeting one body's requirements does not replace the other's.
This article complements Article 4, which deals with radioactive medical materials, requiring the Food and Drug Authority's approval of their technical and clinical specifications before they are licensed by the Nuclear and Radiological Regulatory Commission. Article 4 concerns radioactive materials, while Article 5 concerns radiation emitted from devices.
The article does not set out the conditions or procedures for the radiation protection license, which are regulated by the body responsible for it. A person who runs an establishment that uses devices emitting radiation may need to consult a lawyer who specializes in health and commercial regulations to understand his obligations to both bodies.
Practical example
A dental clinic in Makkah bought an X-ray machine registered with the Saudi Food and Drug Authority. Registering the device does not remove the Nuclear and Radiological Regulatory Commission's jurisdiction to issue the license for protection from the radiation it emits.
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 5 of the Saudi Medical Devices Law
Is registering an X-ray machine with the Food and Drug Authority enough?
The article provides 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, so that license remains within its jurisdiction.
What is the difference between Article 4 and Article 5?
Article 4 concerns radioactive medical materials and their specifications, while Article 5 preserves the Nuclear and Radiological Regulatory Commission's jurisdiction over the radiation protection license for radiation emitted by medical devices.
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 4
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.
مع مراعاة اختصاصات هيئة الرقابة النووية والإشعاعية بإصدار التراخيص اللازمة لممارسة الأنشطة المتعلقة باستخدام المواد الطبية المشعة؛ يشترط موافقة الهيئة على الموا
- 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.