Article 7 of the Saudi Medical Devices Law
المادة 7 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
على المرخص له بإجراء التحقق من الدراسات السريرية؛ الحصول على موافقة الهيئة قبل البدء في أي من عمليات التحقق، وفقًا لما تحدده اللائحة.
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 7 explained in plain English
This article concerns a sensitive activity, verifying clinical studies, which under Article 1 is applied research in which a medical device or supply is used on one or more persons to assess its safety and adequacy when used.
The article imposes two layers of control:
- The body must already be licensed to carry out this activity. It is one of the activities subject to the Law under Article 2, and it may be practiced only after registration and licensing under Article 6.
- That licensed body must obtain the Authority's approval before starting any verification process. The general license is not enough on its own. Each process requires prior approval.
The reason is clear: these studies are carried out on people, so prior oversight of each study is needed to protect those taking part.
The article does not set the approval procedures, documents or periods. It refers them to the Implementing Regulations. Research bodies and companies that want to conduct these studies should therefore consult the Regulations, or a lawyer who specializes in health and commercial regulations, before starting.
Practical example
A company in Jeddah licensed to verify clinical studies wants to test a new blood sugar monitor on a number of volunteers. Despite its license, it cannot begin the study until it obtains the Authority's approval for this specific process.
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 7 of the Saudi Medical Devices Law
Is a license enough to conduct a clinical study on a medical device?
No. The article requires the licensee to obtain the Authority's approval before starting any verification process.
What is meant by verifying clinical studies?
Under Article 1, it is applied research in which a medical device or supply is used on one or more persons to assess its safety and adequacy when used.
Where are the procedures for obtaining approval?
The article refers their details to what the Implementing Regulations determine.
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 6
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.
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 الحص
- 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.