Article 2 of the Saudi Medical Devices Law
المادة 2 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
تخضع لأحكام النظام الأنشطة الآتية:
1- تصميم الأجهزة والمستلزمات الطبية، وتصنيعها.
2- استيراد الأجهزة والمستلزمات الطبية، وتسويقها، وتوزيعها، وتخزينها.
3- تقديم خدمات التحقق من مطابقة الأجهزة والمستلزمات الطبية للوائح الفنية ونظام إدارة الجودة، والتحقق من توكيد الجودة.
4- إجراء التحقق من الدراسات السريرية.
5- تقديم الخدمات الاستشارية الفنية في مجال الأجهزة والمستلزمات الطبية.
6- تقديم خدمات فحص الأجهزة والمستلزمات الطبية للتأكد من مطابقتها للوائح الفنية والمواصفات القياسية.
7- تقديم خدمات الصيانة للأجهزة والمستلزمات الطبية.
8- تمثيل المصنع المقيم خارج المملكة.
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 2 explained in plain English
This article sets out the scope of the Law in terms of activities. Anyone who practices any of the following activities is subject to its provisions:
- Designing and manufacturing medical devices and supplies.
- Importing, marketing, distributing and storing them.
- Providing services to verify their conformity with the technical regulations and the quality management system, and verifying quality assurance.
- Verifying clinical studies.
- Providing technical advisory services in the field.
- Providing services to inspect them to confirm their conformity with the technical regulations and standard specifications.
- Providing maintenance services for them.
- Representing a manufacturer residing outside the Kingdom.
The list shows that the Law is not limited to manufacturers and importers. It extends to service providers such as maintenance, inspection and consulting companies, and even to mere storage. Knowing whether your activity falls within this list is an important first step, because Article 6 prohibits practicing any of the activities subject to the Law except after registration and obtaining a license.
Article 3 completes this scope by treating accessories to devices and assembled devices as medical devices and supplies. If your establishment's activity sits on the border between these categories, it may help to consult a lawyer who specializes in health and commercial regulations.
Practical example
A small company in Jeddah provides maintenance for blood pressure monitors and oxygen devices for hospitals. Under this article, providing maintenance services for medical devices is an activity subject to the Law, so the company must follow the registration and licensing requirements the Law imposes before carrying out its work.
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 2 of the Saudi Medical Devices Law
Is storing medical devices subject to the Law?
Yes. Item 2 of the article covers importing, marketing, distributing and storing medical devices and supplies.
Are medical device maintenance companies covered by the Law?
Yes. Providing maintenance services for medical devices and supplies is one of the activities subject to the Law under item 7.
Is representing a foreign manufacturer an activity subject to the Law?
Yes. Representing a manufacturer residing outside the Kingdom is the eighth activity in the list.
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 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.
- 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.