Article 11 of the Saudi Medical Devices Law
المادة 11 من نظام الأجهزة والمستلزمات الطبية
The article bars clearing imported medical devices and supplies except after the approval of the Saudi Food and Drug Authority.
Official text (Arabic)
This article has not been amended since the law was issued.
لا يجوز فسح الأجهزة والمستلزمات الطبية المستوردة إلَّا بعد موافقة الهيئة.
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 11 explained in plain English
This article places a control at the border on medical devices and supplies. None may be cleared on import except after the approval of the Saudi Food and Drug Authority.
Clearance is the release of the imported shipment so that it enters the Kingdom. The rule here is general. It covers imported medical devices and supplies without the text distinguishing between one type and another.
How does this article connect with others?
- Importing is one of the activities subject to the Law under Article 2, so the importer needs registration and licensing under Article 6.
- An imported device may not be circulated except after registration and the marketing authorization under Article 8.
- Article 13 provides a special case in which the Authority allows devices for personal use to enter with a medical report and in limited quantities.
The article does not set the procedures for requesting approval or its period. An importer whose shipment is delayed or rejected may need to consult a lawyer who specializes in health and commercial regulations to understand the options available.
Practical example
A distribution company in Riyadh imported a shipment of medical gloves and oxygen monitors. The shipment cannot be released from the customs port until the Saudi Food and Drug Authority approves its clearance.
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 11 of the Saudi Medical Devices Law
Can a shipment of medical devices be cleared without Food and Drug Authority approval?
No. The article bars clearing imported medical devices and supplies except after the Authority's approval.
Is there an exception for personal medical devices?
Article 13 allows the Authority to permit devices for personal use to enter based on a medical report and in limited quantities, provided they are not used for a commercial purpose.
More articles on Importing and Clearing Medical Devices
- Article 13
The article allows the Authority to permit medical devices and supplies for personal use to enter with a medical report and in limited quantities, with no commercial purpose.
للهيئة السماح بدخول الأجهزة والمستلزمات الطبية ذات الاستخدام الشخصي؛ بناءً على تقرير طبي وبكميات محدودة، على ألَّا تُستخدم لأي غرض تجاري.
- Article 14
The article requires anyone who dispensed or sold an adulterated, unregistered or unauthorized medical device to notify the Authority as soon as he learns of it and to refund the buyer's price.
على كل من صرف أو باع جهازًا أو مستلزمًا طبيًّا مغشوشًا، أو غير مسجل، أو غير حاصل على الإذن بالتسويق، إبلاغ الهيئة -فور علمه بذلك- بالمعلومات التي تتعلق بما صُرف
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.