Article 25 of the Saudi Medical Devices Law
المادة 25 من نظام الأجهزة والمستلزمات الطبية
The article bars holding awareness campaigns, charitable campaigns or the like relating to 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 إقامة حملات توعية أو حملات خيرية أو ما في حكمهما متعلقة بالأجهزة والمستلزمات الطبية، 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 25 explained in plain English
This article complements Article 24 on advertising and announcing, and extends to another kind of activity that may not look commercial on its face: awareness campaigns, charitable campaigns and the like relating to medical devices and supplies.
The rule: these campaigns may not be held except after:
- The Authority's approval.
- Compliance with the conditions set by the Regulations.
The phrase "and the like" means the rule is not limited to what is literally called an awareness or charitable campaign, but includes similar activities.
The reason is that free or charitable campaigns may involve distributing devices or giving information about their use, and so need oversight to ensure safety. Note that distributing devices free of charge counts as circulation under the definition in Article 1, so the device itself needs registration and the marketing authorization under Article 8.
The article concerns companies, charities and bodies that organize health events. Before announcing a campaign of this kind, it is advisable to obtain the Authority's approval, and to consult a lawyer who specializes in health and commercial regulations when needed.
Practical example
A charity in Al-Ahsa plans a campaign to distribute blood glucose meters free to elderly people, with an awareness talk. It must obtain the Authority's approval before holding the campaign, and comply 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 25 of the Saudi Medical Devices Law
Does a charitable campaign to distribute medical devices need approval?
Yes. The article bars holding charitable campaigns relating to medical devices and supplies except after the Authority's approval and under the Regulations' conditions.
Does the article cover health awareness campaigns?
It covers awareness campaigns relating to medical devices and supplies and the like.
More articles on Advertising Medical Devices
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.

