Article 13 of the Saudi Medical Devices Law

المادة 13 من نظام الأجهزة والمستلزمات الطبية

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.

Official text (Arabic)

This article has not been amended since the law was issued.

للهيئة السماح بدخول الأجهزة والمستلزمات الطبية ذات الاستخدام الشخصي؛ بناءً على تقرير طبي وبكميات محدودة، على ألَّا تُستخدم لأي غرض تجاري.

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 13 explained in plain English

This article addresses a situation many individuals face: needing to bring in a medical device or supply for personal use, such as a device for a patient or therapeutic supplies that a particular person needs.

The rule under Article 11 is that imported devices are not cleared except with the Authority's approval. This article allows the Authority to permit devices for personal use to enter, under conditions that must all be met:

That this is based on a medical report.
That they are in limited quantities.
That they are not used for any commercial purpose.

Note that the text says "the Authority may permit", meaning the matter is discretionary and left to the Authority's judgment, and is not an automatic right of everyone holding a medical report. The article also does not specify the amount of "limited quantities", so no particular figure should be assumed.

The third condition is essential: if personal use is used as a cover for selling devices, this falls outside the article and may amount to circulating unregistered devices, which is barred under Article 8. Someone who faces a problem bringing in a personal device can contact the Authority or consult a lawyer who specializes in health and commercial regulations.

Practical example

Sara lives in Taif, and her son needs special supplies for an insulin pump that she bought abroad. The Authority may allow them to enter based on a medical report proving her son's need, in a limited quantity, as long as she will not sell them or use them commercially.

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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