Article 49 of the Saudi Medical Devices Law
المادة 49 من نظام الأجهزة والمستلزمات الطبية
The article sets the start of effect of the Medical Devices and Supplies Law at 180 days after its publication in the Official Gazette.
Official text (Arabic)
This article has not been amended since the law was issued.
يعمل بالنظام بعد (مائة وثمانين) يومًا من تاريخ نشره في الجريدة الرسمية.
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 49 explained in plain English
This article sets the date the Law takes effect, that is, the moment its provisions become binding on establishments and individuals.
The rule: the Law takes effect 180 days after the date of its publication in the Official Gazette. The Law is not applied from the day it is issued or published, but after this period has passed.
The purpose of this period: to give establishments working in the field of medical devices and supplies, such as manufacturers, importers, distributors and service providers, time to prepare for the new obligations, such as registration and licensing, applying the quality management system and appointing an authorized representative.
The link to the Regulations: Article 48 provides that the Board issues the Regulations within 180 days of the date the Law is published, and that they take effect from the date the Law takes effect. The two periods are equal, so the Law and its Regulations begin to apply at the same time.
The practical effect: the starting point for the calculation is the date of publication in the Official Gazette. Determining whether a particular incident falls under this Law according to the date it occurred is a matter that needs to be looked at case by case, and a lawyer who specializes in health and commercial regulations can be consulted.
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 49 of the Saudi Medical Devices Law
When does the Medical Devices and Supplies Law take effect?
180 days after the date of its publication in the Official Gazette.
Do the Regulations take effect at the same time?
Yes. Article 48 provides that the Regulations take effect from the date the Law takes effect.
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 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.
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.