Article 6 of the Saudi Medical Devices Law
المادة 6 من نظام الأجهزة والمستلزمات الطبية
The article bars any establishment from practicing the Law's activities except after registration and obtaining a license, with an industrial license for factories, subject to Article 4.
Official text (Arabic)
This article has not been amended since the law was issued.
مع مراعاة ما ورد في المادة (الرابعة) من النظام؛ لا يجوز لأي منشأة ممارسة أيٍّ من الأنشطة الخاضعة للنظام؛ إلَّا بعد التسجيل، والحصول على الترخيص، إضافةً إلى الحصول على الترخيص الصناعي من الجهة المختصة بالنسبة إلى المصانع.
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 6 explained in plain English
This article is the basic rule for entering the market. No establishment may practice any of the activities subject to the Law, listed in Article 2, except after meeting the following:
- Registration: that is, entering the establishment in the national register of establishments, medical devices and supplies kept by the Authority, as defined in Article 1.
- Obtaining a license: the document the Authority issues to practice the activity.
- An industrial license from the competent body: this is an additional requirement for factories only.
The article begins with the phrase "subject to what is stated in Article 4", meaning that this requirement is applied subject to what Article 4 provides on radioactive medical materials: the Nuclear and Radiological Regulatory Commission's jurisdiction to issue licenses for activities relating to them, and the requirement of the Saudi Food and Drug Authority's approval of their technical and clinical specifications beforehand.
This article does not set out the conditions and procedures for registration and licensing. Article 10 refers their determination to the Implementing Regulations. Someone planning to set up an establishment in this field, such as a warehouse, a maintenance company or an import business, should start with registration and licensing before any activity, and can consult a lawyer who specializes in health and commercial regulations when needed.
Practical example
Khalid wants to open a warehouse in Riyadh to store medical supplies and distribute them to pharmacies. He may not begin storing or distributing before registering his establishment with the Authority and obtaining the license. If he were opening a factory, he would also need the industrial license from the competent body.
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 6 of the Saudi Medical Devices Law
Can a medical device business start before obtaining a license?
No. The article bars any establishment from practicing any activity subject to the Law except after registration and obtaining a license.
Does a medical device factory need an additional license?
Yes. In addition to registration and the license, the article requires factories to obtain the industrial license from the competent body.
Where do I find the licensing conditions and procedures?
Article 10 refers the determination of the conditions and procedures for registration and licensing to the Implementing Regulations.
Articles this article refers to
More articles on Registration and Licensing of Establishments
- 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 7
The article requires a licensee to obtain the Authority's approval before starting any process of verifying clinical studies, in accordance with the Implementing Regulations.
على المرخص له بإجراء التحقق من الدراسات السريرية؛ الحصول على موافقة الهيئة قبل البدء في أي من عمليات التحقق، وفقًا لما تحدده اللائحة.
- Article 10
The article refers to the Regulations the conditions and procedures for registration, issuing the marketing authorization, and for the license and its renewal, amendment, transfer and cancellation.
تحدد اللائحة الشروط والإجراءات اللازمة للتسجيل، وإصدار الإذن بالتسويق، والحصول على الترخيص وتجديده وتعديله ونقله وإلغائه.
- Article 18
The article requires a health care provider not to deal with any establishment in the Law's activities unless it is registered and licensed in the same field of dealing.
يلتزم مقدم الرعاية الصحية بألَّا يتعامل مع أي منشأة تزاول أيًّا من الأنشطة الخاضعة للنظام؛ ما لم تكن مسجلة وحاصلة على ترخيص في مجال التعامل نفسه.
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.