Article 14 of the Saudi Medical Devices Law
المادة 14 من نظام الأجهزة والمستلزمات الطبية
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.
Official text (Arabic)
This article has not been amended since the law was issued.
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 أو بِيع وكميته، واسم من صُرِف أو بِيع له الجهاز أو المستلزم الطبي وعنوانه، ويلتزم بإعادة الثمن للمشتري.
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 14 explained in plain English
This article imposes two obligations on anyone who dispensed or sold a medical device or supply that falls into one of three situations:
- Adulterated: that is, its identity or source was deliberately altered with the intent to deceive, or its contents changed in a way that harms its safety, or it was packed in counterfeit packaging, under Article 1.
- Unregistered.
- Without a marketing authorization.
First obligation: notify the Authority as soon as he learns of it, with the information about what was dispensed or sold, its quantity, and the name and address of the person it was dispensed or sold to. The aim is to enable the Authority to trace the devices that have reached people.
Second obligation: refund the price to the buyer. The article expressly states the seller's obligation to refund the price.
Note that the notification obligation is tied to the moment of knowledge: it arises "as soon as he learns of that". The article does not address the seller's criminal liability, which is governed by the Law's provisions on violations and penalties.
For the buyer, the article gives a clear text on the right to get the price back. If the seller refuses, or there is harm beyond the price, it is advisable to consult a lawyer who specializes in health and commercial regulations.
Practical example
A pharmacy in Abha sold glucose meters and then learned they were not registered with the Authority. It must notify the Authority immediately of the number of devices sold and the names and addresses of the buyers, and refund the price to everyone who bought from it.
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 14 of the Saudi Medical Devices Law
Am I entitled to a refund for an adulterated medical device?
Yes. The article requires anyone who sold an adulterated, unregistered or unauthorized device to refund the price to the buyer.
When must the seller notify the Authority?
As soon as he learns that the device is adulterated, unregistered or without a marketing authorization.
What information must be reported?
The information about what was dispensed or sold and its quantity, and the name and address of the person it was dispensed or sold to.
More articles on Importing and Clearing Medical Devices
- Article 11
The article bars clearing imported medical devices and supplies except after the approval of the Saudi Food and Drug Authority.
لا يجوز فسح الأجهزة والمستلزمات الطبية المستوردة إلَّا بعد موافقة الهيئة.
- 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.
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.

