Article 10 of the Saudi Medical Devices Law
المادة 10 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
تحدد اللائحة الشروط والإجراءات اللازمة للتسجيل، وإصدار الإذن بالتسويق، والحصول على الترخيص وتجديده وتعديله ونقله وإلغائه.
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 10 explained in plain English
This is a referral article. It sets no conditions itself, but instructs the Implementing Regulations to determine the conditions and procedures for several matters:
- Registration in the national register, for establishments, devices and supplies.
- Issuing the marketing authorization for medical devices and supplies.
- Obtaining the license to carry out the activities.
- Renewing, amending, transferring and cancelling the license.
The practical meaning is that anyone who wants to know the required documents, the periods or the cases in which a license is cancelled must consult the Regulations, not the Law itself. The Law set the principle in Article 6, which bars an establishment from practicing the activity before registration and licensing, and in Article 8, which bars circulating a device before registration and the marketing authorization, and left the details to the Regulations.
Note that the article mentioned the transfer of the license among the matters the Regulations govern, which means that transfer is possible in principle, but its conditions and procedures are set by the Regulations. When you need to renew or transfer, or to object to a cancellation, it is advisable to consult a lawyer who specializes in health and commercial regulations.
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 10 of the Saudi Medical Devices Law
Where do I find the conditions for registering a medical device?
The article refers the determination of the conditions and procedures for registration and issuing the marketing authorization to the Law's Implementing Regulations.
Can the license of a medical device establishment be transferred?
The article lists transfer of the license among the matters whose conditions and procedures the Regulations determine.
Does the Law itself set the license period?
This article sets no period. It refers the conditions of the license and its renewal to the Regulations.
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 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 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.