Article 48 of the Saudi Medical Devices Law
المادة 48 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
يصدر المجلس اللائحة خلال (مائة وثمانين) يومًا من تاريخ نشر النظام في الجريدة الرسمية، ويعمل بها من تاريخ نفاذه.
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 48 explained in plain English
This article concerns the Law's Implementing Regulations, the document to which the Law refers important details in many places, such as the conditions for registration, licensing and the marketing authorization in Article 10, the conditions for the free sale certificate in Article 12, and the identifying information in Article 17.
The article sets three things:
- The issuing body: the Board, that is, the board of directors of the Saudi Food and Drug Authority under Article 1.
- The period: within 180 days of the date the Law is published in the Official Gazette.
- Date of effect: from the date the Law takes effect.
The reason for linking the Regulations' date of effect to the Law's is so that both begin together, so the Law is not applied without its implementing details. Article 49 provides that the Law takes effect 180 days after its publication in the Official Gazette, which is the same period set for issuing the Regulations.
The practical effect for the reader: when looking into any obligation whose details the Law refers to "the Regulations", the reference is these Regulations issued by the Board.
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 48 of the Saudi Medical Devices Law
Who issues the Implementing Regulations of the Medical Devices Law?
The Board issues them, which is the board of directors of the Saudi Food and Drug Authority.
When do the Implementing Regulations take effect?
From the date the Law takes effect, according to the text of the article.
What is the period set for issuing the Regulations?
Within 180 days of the date the Law is published in the Official Gazette.
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 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 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.