Article 24 of the Saudi Medical Devices Law
المادة 24 من نظام الأجهزة والمستلزمات الطبية
The article bars advertising, announcing and promoting medical devices and supplies except after the Authority's approval and under the Regulations' conditions.
Official text (Arabic)
This article has not been amended since the law was issued.
لا تجوز الدعاية للأجهزة والمستلزمات الطبية ولا الإعلان عنها ولا الترويج لها، إلَّا بعد موافقة الهيئة ووفقًا للشروط التي تحددها 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 24 explained in plain English
This article restricts advertising, announcing and promoting medical devices and supplies. None of these is permitted except after two things are both met:
- The approval of the Saudi Food and Drug Authority.
- Compliance with the conditions set by the Regulations.
Note that the article mentions three acts: advertising, announcing and promoting, which shows how broad its scope is. The article does not distinguish between one means and another, and does not limit the rule to a particular advertising medium.
The approval must come before the advertisement. The text says "except after the Authority's approval", so obtaining approval after publishing the advertisement is not enough. Approval alone is also not enough. The Regulations' conditions, which the text does not set out in detail, must be complied with.
This article is linked to Article 25, which sets a similar rule for awareness campaigns and charitable campaigns relating to medical devices and supplies. Circulating the device itself also requires registration and the marketing authorization under Article 8.
The rule concerns manufacturers, distributors, online stores and those engaged to promote. Before launching a marketing campaign for a medical product, it is advisable to check for approval and consult a lawyer who specializes in health and commercial regulations.
Practical example
An online store in Jeddah sells blood pressure monitors and wants to hire a social media influencer to promote them. It may not publish this promotion before obtaining the Authority's approval and complying with the conditions set by the 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 24 of the Saudi Medical Devices Law
Does advertising a medical device need approval?
Yes. The article bars advertising, announcing and promoting medical devices and supplies except after the Authority's approval and under the Regulations' conditions.
Is it enough to get approval after the advertisement is published?
No. The text requires that the advertising come after the Authority's approval.
Does the rule cover promotion through social media?
The article covers advertising, announcing and promoting without limiting them to a particular medium.
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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.

